A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.

Start Date23 Aug 2024

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

CTR20242669 / Active, not recruitingNot Applicable

甲苯磺酸卢美哌隆胶囊在健康受试者中的单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉的空腹及餐后状态下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover bioequivalence study of lumepirone tosylate capsules in healthy subjects under fasting and fed conditions

主要研究目的：以江苏恩华药业股份有限公司研制的甲苯磺酸卢美哌隆胶囊（规格：42 mg）为受试制剂，以Intra-Cellular Therapies Inc.持证的甲苯磺酸卢美哌隆胶囊（商品名：Caplyta®，规格：42 mg）为参比制剂，研究受试制剂和参比制剂在健康受试者中空腹及餐后单次给药的药代动力学特征，进行人体生物等效性评价。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to use Lumiperone Tosylate Capsules (Specification: 42 mg) developed by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation and Lumiperone Tosylate Capsules (trade name: Caplyta®, Specification: 42 mg) certified by Intra-Cellular Therapies Inc. as the reference preparation to study the pharmacokinetic characteristics of the test preparation and the reference preparation in healthy subjects after single administration on an empty stomach and after meals, and to evaluate the bioequivalence in humans. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date20 Jul 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

NCT06462612 / RecruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Start Date17 Jul 2024

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

Literatures (Medical) associated with Lumateperone Tosylate

01 Sep 2024·CNS DRUGS

Pharmacological Treatment of Binge Eating Disorder and Frequent Comorbid Diseases

Review

Author: McElroy, Susan L ; Bentley, Jessica ; Himmerich, Hubertus

Binge eating disorder (BED) is the most common specific eating disorder (ED). It is frequently associated with attention deficit hyperactivity disorder (ADHD), depression, bipolar disorder (BD), anxiety disorders, alcohol and nicotine use disorder, and obesity. The aim of this narrative review was to summarize the evidence for the pharmacological treatment of BED and its comorbid disorders. We recommend the ADHD medication lisdexamfetamine (LDX) and the antiepileptic and antimigraine drug topiramate for the pharmacological treatment of BED. However, only LDX is approved for the treatment of BED in some countries. Medications to treat diseases frequently comorbid with BED include atomoxetine and LDX for ADHD; citalopram, fluoxetine, sertraline, duloxetine, and venlafaxine for anxiety disorders and depression; aripiprazole for manic episodes of BD; lamotrigine, lirasidone and lumateperone for depressive episodes of BD; naltrexone for alcohol use disorder; bupropion for nicotine use disorder; and liraglutide, semaglutide, and the combination of bupropion and naltrexone for obesity. As obesity is a frequent health consequence of BED, weight gain-inducing medications, such as the atypical antipsychotics olanzapine or clozapine, the novel antidepressant mirtazapine and tricyclic antidepressants, and the mood stabilizer valproate should be avoided where possible. It is currently unclear whether the novel and promising glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) receptor agonists like tirzepatide and retatrutide help with BED and its comorbidities. However, these compounds have been reported to reduce binge eating in individuals with obesity or overweight.

01 Aug 2024·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Metabolic profiling of lumateperone in vitro and in vivo by UPLC-Q Exactive Orbitrap HRMS, and its pharmacokinetic study in rat plasma by LC-MS/MS

Article

Author: Wang, Wenyan ; Qiu, Yifan ; Zhang, Wenjing ; Chen, Jindong ; Guo, Jing

Lumateperone is a novel agent approved by FDA for treatment of schizophrenia in adults. To elucidate the species differences in the of biotransformation of lumateperone and its pharmacokinetic (PK) characteristics in rats, the metabolite identification of lumateperone was carried out in rat, dog and human liver microsomes, and rat plasma after oral administration using UPLC-Q Exactive Orbitrap high-resolution mass spectrometry HRMS. Furtherly, the PK characteristics of lumateperone and its N-demethylated metabolite (M3) in rat plasma were investigated using a validated LC-MS/MS method following intravenous and oral administration. Fourteen phase I metabolites were found in liver microsomes and ten of them were observed in rat plasma. N-demethylation, carbonylation, dehydrogenation, and piperazine ring cleavage were main metabolic pathway of lumateperone. No unique metabolites were formed in human liver microsomes. After rapid absorption in rats, lumateperone was quickly metabolized and eliminated with bioavailability of less than 5%. The exposure level of M3 was about 1.5-fold higher than that of lumateperone in rat plasma. Lumatperone underwent extensive metabolism and was absorbed rapidly in rats. Metabolite M3 had equivalent or slightly higher exposure levels than lumateperone. This study provides essential PK information to facilitate further pharmacodynamic researches of lumateperone.

08 Jul 2024·Psychopharmacology bulletin

The Black Book of Psychotropic Dosing and Monitoring.

Review

Author: DeBattista, Charles ; Schatzberg, Alan F

Introduction Since the last edition of the Black Book, several innovative agents have been approved or are poised to be approved in the coming year. These include novel antidepressants, the first muscarine agonist for the treatment of schizophrenia, the first psychedelic which may be approved for the treatment of PTSD (Post Traumatic Stress Disorder), and the first disease modifying drug for the treatment of Alzheimer's disease. Three new antidepressants have come to the market in the past 18 months. The first of those, Auvelity, the combination of bupropion and dextromethorphan, takes advantage of a pharmacokinetic and pharmacodynamic synergism between the two drugs.⁸⁵ Dextromethorphan has several pharmacodynamic properties including actions on the NMDA receptor and the Sigma 1 receptor, adding to the indirect norepinephrine agonist properties of bupropion. How Dextromethorphan is rapidly metabolized via the CYP2D6 isoenzyme to dextrophan that may have mu opioid agonist properties. The combination with bupropion, a CYP2D6 inhibitor, inhibits the metabolism of dextromethorphan allowing for more consistent therapeutic levels. The combination of dextromethorphan 45 mg twice per day and bupropion SR 105 mg twice daily appears to be more effective than an equivalent dose of bupropion alone both in speeding up antidepressant response and achieving remission. However, it's not clear at this time how the combination would compare with a more typical dose of bupropion of 300-450 milligrams a day range. The phase III program for Auvelity, showed that the drug was well tolerated with the most common side effects being dizziness, headache, and dry mouth.⁸⁶ Another novel antidepressant agent approved in 2023 is zuranolone (Zurzuvae). Zuranolone is an oral analog of IV brexanalone, and like brexanolone, was approved for the treatment of post-partum depression.⁸³ The advantages of zuranolone over brexanalone are many. While brexanolone is a 60-hour intravenous infusion that must be administered in a health care facility, zuranolone is a once/day oral medication that is usually taken at home. Like brexanolone, and unlike most antidepressants, zuranolone has a short course of treatment, lasting just 14 days. Zuranolone's, as does brexanolone, is thought to act primarily as allosteric modulator of the GABA-a receptors. Despite only 14 days of treatment, zuranolone produced in depression in post-partum patients a clinically and significantly meaningful improvement at day 15 and continued to day 45 or 1 month past the end of treatment. Zuranolone is a schedule IV drug. The most common side effect in clinical trials was somnolence with 36% of participants reporting this side effect vs only 6% of those on placebo.⁸⁴ Other common side effects included dizziness, diarrhea and fatigue. While the FDA declined to approve zuranolone as monotherapy or as an adjunctive treatment to standard antidepressants in major depression itself, there are positive studies in non-post-partum major depression albeit with smaller effect sizes and less consistent duration of activity. It is likely that zuranolone will continue to be studied in other depressive syndromes such as depression with anxious distress. The third "new" antidepressant approved late 2023 was gepirone (Exxua). Gepirone is not exactly a new or novel antidepressant and originally sought approval in the US about 20 years ago.⁸⁸ There had been two positive studies of gepirone during the original NDA application but also a number of failed, negative, or non-informative studies as well. Thus, the FDA declined to originally approve the drug. However, failed and negative trials are common with antidepressants and after much internal debate, the FDA ultimately agreed to approve the drug based on the positive trials and a relatively favorable side effect profile. Gepirone, like buspirone, is a partial agonist of the 5HT1a receptor and a 5HT2 antagonist. As such, gepirone does not tend to be associated with sexual side effects, weight gain, or sedation. The most common side effects are dizziness, nausea, and insomnia which tend to improve in many patients over time. Second generation antipsychotics (SGAs) continue to be the only class of agents [other than esketamine (Spravato)] approved in adjunctive treatment of resistant major depression. In addition to olanzapine (combined with fluoxetine; Symbyax), aripiprazole (Abilify), quetiapine (Seroquel), brexpiprazole (Rexulti), cariprazine (Vraylar) became the latest SGA to be approved in 2022.⁹⁰ Adjunctive cariprazine at 1.5 mg daily was significantly more effective than adjunctive placebo in patients with MDD who had failed to achieve an adequate response with an antidepressant alone after 6 weeks of treatment. Interestingly, a 3 mg dose of cariprazine was less consistently effective.⁹¹ The major advantage of cariprazine over some of the other approved adjunctive SGA's is easy dosing, with the starting 1.5 mg dose being the optimal therapeutic dose for most people, and a lower metabolic side effect burden with most subjects having limited or no weight gain in short term trials. The most common side effect were akathisia/restlessness, fatigue, and nausea. Lumateperone (Caplyta) is also has positive phase III data in the adjunctive treatment of major depression and is expective file for approval in late 2024. Another recent major development in psychopharmacology is the reemergence of psychedelics in the treatment of psychiatric disorders. The first of these is MDMA (phenethylamine 3,4-methylenedioxymethamphetamine) assisted psychotherapy for the treatment of PTSD. A New Drug Application (NDA) was accepted by the FDA for MDMA in the treatment of PTSD in late 2023.⁸⁷ Because the drug is being fast tracked as a "breakthrough" treatment by the FDA, it was expected to see approval in the summer of 2024. The phase II and III data for MDMA assisted psychotherapy in the treatment of PTSD have been quite consistent and impressive. However, independent reviews have pointed to significant deficiencies in these studies including the bias introduced because of functional unblinding; virtually all patients in psychedelic studies can guess whether they got the active drug or placebo. The functional unblinding, the lack of standardization of adjunctive psychotherapy as well as the abuse potential of MDMA, may delay an FDA approval. The typical regimen in these trials included 3 preparatory psychotherapy sessions followed by once/month dosing sessions (lasting about 8 hours) and using doses of 120-160 mg in a split dose. There were typically 3 monthly dosing sessions, each followed by 3 integrative psychotherapy sessions to help subjects process and understand their experiences during the dosing sessions. In the most recent phase 3 trials, over 70% of subjects no longer met criteria for PTDS compared to 46% of those treated with psychotherapy and placebo alone.⁸⁹ The only approved medications for treating PTSD are two SSRIs, paroxetine and sertraline. These drugs effect only some dimensions of PTSD with only 20-30% achieving a remission level response with these drugs. Thus, MDMA assisted psychotherapy appears to achieve much higher levels of remission and response than has been true for the SSRIs. Since MDMA is not taken continuously, side effects from MDMA tend to be short lived. Side effects have included muscle tightness, nausea, diminished appetite, excessive sweating, feeling cold and dizziness among others. Since MDMA is currently a schedule I drug, it is likely that a rigorous Risk Evaluation Mitigation (REMs) program will be put in place and a limited number of centers and clinicians will be designated to perform MDMA assisted psychotherapy for PTSD. In addition to MDMA, psilocybin-assisted psychotherapy is in phase 3 trials for treating resistant depression but unlikely to be available before late 2025 at the earliest. An argument can be made that there has not been a truly novel antipsychotic since the introduction of clozapine in the US in 1990. All first-generation antipsychotics have been dopamine 2 antagonists and second-generation drugs have involved some ratio of 5HT2 antagonism to D2 blockade. In 2023, the FDA accepted the application of xenomaline/tropsium (KarXT) which may become the first muscarinic M1M4 agonist approved for the treatment of schizophrenia.^82,83 Tropsium is added as a muscarine antagonist to block the peripheral cholinergic effects of a muscarine agonist. Xenomaline/tropsium appears to be effective in treating both positive and negative symptoms of schizophrenia. In a phase 3 study of 407 patients with schizophrenia, xenomaline/tropsium at doses of xenomaline/50 mg/tropsium 20 mg twice daily up to 125 mg/30 mg twice daily was significantly more effective than placebo in treating both and negative symptoms over 5 weeks of treatment. As would be expected, the side effect profile of xenomaline/tropsium is very different that all currently available antipsychotics. There is no risk of EPS as it is not a dopamine antagonist, and xenomaline/tropsium is not associated with significant metabolic effects. The side effects are cholinergic in nature and include constipation, dry mouth, and nausea. A decision is expected in September of 2024. The year 2023 also saw the approval of the first disease modifying drug in the treatment of Alzheimer's disease, lecanemab (Lequembi). While acetylcholinesterase inhibitors and memantine have been available for decades, these drugs modestly improve cognition in Alzheimer's disease patients and do not alter the progressive course of the illness. Lecanemab is an IV monoclonal antibody that targets the removal of beta-amyloid in the brain as well proto-fibrils that are also known to be toxic to neuronal tissue. When given early in the course of the illness, patients treated with Lecanemab showed 27% less decline on some measures of cognition and function than did patients treated with a placebo over 18 months (about 1 and a half years). It is not known whether treatment for longer than 18 months would show lesser or greater decline over time. However, there are simulation studies that suggest that Lecanemab may modestly reduce the number of patients who progress to severe Alzheimer's disease and require institutional care. The standard dose is 10 mg/kg given via IV over one hour every 2 weeks for 18 months. Lecanemab is typically administered in an infusion center so that side effects can be monitored. The most serious side effects of Lecanemab are amyloid related imaging abnormalities (ARIA) that are associated with brain edema and microhemorrhages. ARIA can occur in up to 15% of patients. More common side effects are headache and nausea. While it remains to be seen how useful these new agents will be in clinical practice, they do represent an approach to treating neuropsychiatric disorders that are a notable departure from the pharmacotherapy of the past half century. It seems likely that some patients who have not been able to respond to or tolerate traditional pharmacotherapy will find hope in these new medications.

News (Medical) associated with Lumateperone Tosylate

23 Sep 2024

·www.globenewswire.com

Intra-Cellular Therapies Announces Presentations at the 2024 European College of Neuropsychopharmacology Congress

Oral and poster presentations of results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Poster presentations of post-hoc analyses from Study 403 including the prespecified patient population with MDD or bipolar depression with mixed features who also had anxious distress NEW YORK, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced presentations of lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder (MDD), Study 501 at the 37th European College of Neuropsychopharmacology (ECNP) Congress being held September 21 - 24, 2024 in Milan, Italy. “We are very pleased to present additional lumateperone data across depressive disorders including remarkable positive results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD at ECNP. The robust efficacy demonstrated by lumateperone, coupled with its favorable safety and tolerability profile, position CAPLYTA to become an important medicine for the treatment of MDD,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “We are on track to submit our lumateperone sNDA for the adjunctive treatment of MDD including the results of Studies 501 and 502 later this year.” Details of the presentations are as follows: Study 501 Presentations Oral presentation: “Adjunctive Lumateperone Significantly Improves Symptoms of Major Depressive Disorder: Topline Results From a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial.” Monday, September 23, 15:00 - 16:20 CEST. P2127: “Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomised, Double-blind, Phase 3 Trial.” Monday, September 23 12:35 - 14:00 CEST. Study 403 Presentations P2113: “Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder With Anxious Distress and Mixed Features.” Monday, September 23 12:35 - 14:00 CEST. P2096: “Lumateperone in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: Efficacy Across Symptoms.” Monday, September 23 12:35 - 14:00 CEST. In Study 501, lumateperone met the primary endpoint of change from baseline at Week 6 on the Montgomery Asberg Depression Rating Scale (MADRS) total score versus placebo with a 4.9-point reduction (p<0.0001; Cohen’s d effect size (ES)= 0.61). Statistically significant reductions in depressive symptoms as measured by the MADRS were seen at the earliest time point tested, Week 1, and these improvements continued throughout the course of the trial. Lumateperone also met the key secondary endpoint of change from baseline on the clinician-rated Clinical Global Impression Scale for Severity of Illness (CGI-S) (p < 0.0001; ES: 0.67). On a patient-reported measure, the Quick Inventory of Depressive Symptomatology Self Report scale (QIDS), patients reported robust reduction in their depressive symptoms (p <0.0001). Adverse events were similar to those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia. Mean changes in key metabolic parameters including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo. In an additional, similarly-designed trial, Study 502, lumateperone 42 mg plus an antidepressant met primary and key secondary efficacy endpoints (MADRS Total Score [LSMD vs placebo=−4.5; ES= 0.56; P<0.0001] and CGI-S score [LSMD vs placebo=−0.5; ES= 0.51; P<0.0001]) and was generally safe and well tolerated in patients with MDD with inadequate antidepressant response. Details of Study 502 will be presented at upcoming conferences. Study 403 presentations highlight important analyses of lumateperone’s double-blind placebo-controlled study in patients with either MDD or bipolar depression exhibiting mixed features. Poster #2113 presents a post-hoc analysis of Study 403 evaluating lumateperone’s efficacy in the prespecified patient population with MDD or bipolar depression with mixed features who also met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for anxious distress. In this analysis, lumateperone significantly improved depression symptoms and severity (MADRS Total score and CGI-S score) compared with placebo. Lumateperone also significantly improved MADRS inner tension single-item score in patients with co-morbid anxious distress. Both anxious distress and mixed features are specified in the DSM-5 and are common in patients with major depressive episodes associated with MDD and bipolar disorder. Patients with these specifiers have more severe symptoms, more comorbidities, increased suicide risk, and/or poorer treatment response than patients without these specifiers. Poster #2096 presents a post-hoc analysis of Study 403 individual MADRS items. Treatment with lumateperone significantly improved a broad range of depression symptoms across individual MADRS items. About Major Depressive Disorder Major Depressive Disorder (MDD) is a common mood disorder in the U.S. affecting an estimated 21 million adults each year. Depressive disorders are the number two cause of years lived with disability in the world. Symptoms include sadness, hopelessness, helplessness, feelings of guilt, irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior. MDD can cause severe functional impairment, adversely affecting interpersonal relationships, and may impact quality of life. Approximately two-thirds of patients with depression fail to achieve remission with first-line treatment. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warning. About CAPLYTA (lumateperone) CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. Lumateperone is being studied for the treatment of major depressive disorder, and other psychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders. About Intra-Cellular Therapies Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com. Forward-Looking Statements This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expectations regarding the commercialization of CAPLYTA; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability or reporting of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or bipolar depression or in ongoing or future trials and other development activities; there is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents; there is no guarantee that our planned sNDA for the treatment of MDD will be submitted or approved, if at all, on the timeline that we expect; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine, Russia and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law. Contact: Intra-Cellular Therapies, Inc.Juan Sanchez, M.D. Vice President, Corporate Communications and Investor Relations646-440-9333 Burns McClellan, Inc.Cameron Radinoviccradinovic@burnsmc.com646-930-4406

Clinical ResultPhase 3Cell TherapyDrug Approval

07 Aug 2024

·www.globenewswire.com

Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales Guidance

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA’s strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD) Supplemental NDA (sNDA) submission for lumateperone as an adjunctive therapy to antidepressants in patients with MDD anticipated in the second half of 2024 Commenced patient enrollment in ITI-1284 Phase 2 Studies in Generalized Anxiety Disorder and Psychosis associated with Alzheimer’s disease NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the second quarter ended June 30, 2024 and provided a corporate update. “We are very pleased with the strong performance of CAPLYTA during the second quarter and look forward to continued growth for the remainder of 2024,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “Our team is also focused on preparing our sNDA for MDD for submission later this year and continues to advance our robust pipeline.” Second Quarter Financial Highlights: Total revenues were $161.4 million for the second quarter of 2024, compared to $110.8 million for the same period in 2023. Net product sales of CAPLYTA were $161.3 million for the second quarter of 2024, compared to $110.1 million for the same period in 2023. Net loss for the second quarter of 2024 was $16.2 million compared to a net loss of $42.8 million for the same period in 2023. Cost of product sales was $11.4 million in the second quarter of 2024 compared to $7.2 million for the same period in 2023. Selling, general and administrative (SG&A) expenses were $121.6 million for the second quarter of 2024, compared to $101.0 million for the same period in 2023. Research and development (R&D) expenses were $56.2 million for the second quarter of 2024, compared to $49.8 million for the same period in 2023. Cash, cash equivalents, investment securities, and restricted cash totaled $1.025 billion at June 30, 2024. Commercial Update CAPLYTA total prescriptions increased 36% in the second quarter of 2024, compared to the same period in 2023 and 10% in the second quarter of 2024, compared to the first quarter of 2024. To fully leverage the growing opportunity with primary care physicians in our current CAPLYTA indications, we plan to increase the size of our sales force during the third quarter of this year to expand our reach and frequency in primary care offices. In connection with this expansion, we are adding approximately 150 sales representatives. We expect to complete a second sales force expansion in 2025 in connection with the potential approval of CAPLYTA for the adjunctive treatment of MDD. Received notification from the Centers for Medicare and Medicaid Services that CAPLYTA qualified for the Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act. Fiscal 2024 Financial Outlook: CAPLYTA full year 2024 net product sales guidance range raised to $650 to $680 million. Full year 2024 SG&A expense guidance range increased to $480 to $510 million. This increase is primarily the result of sales, marketing and other expenses associated with the sales force expansion in the primary care segment in the second half of 2024. Full year 2024 R&D expense guidance range lowered to $210 to $230 million. CLINICAL HIGHLIGHTS Lumateperone: Adjunctive MDD program: Studies 501 and 502 are our global Phase 3 pivotal clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Following the positive and robust results in Study 501 in April 2024 and in Study 502 in June 2024, we anticipate submitting an sNDA with the U.S. Food and Drug Administration (FDA) in the second half of 2024.In these studies, lumateperone robustly met the primary endpoint by demonstrating reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo plus antidepressants at Week 6. Results for the primary endpoint are summarized as follows: Primary Endpoint: Change from baseline vs. placebo on the MADRS Total Score at Week 6 (modified intent-to-treat study population) Least Squares (LS) Mean Reduction vs. Baseline1LS mean difference1p valueCohen's d effect sizeSTUDY 501Lumateperone 42 mg +ADT14.7-4.9<0.00010.61 placebo +ADT9.8 STUDY 502Lumateperone 42 mg+ADT14.7-4.5<0.00010.56 placebo +ADT10.2 1 rounded to nearest tenth; ADT: Antidepressant therapy Similarly, in both pivotal studies, lumateperone met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S). Statistically significant efficacy was also seen in both studies in the patient reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale, a self-reported measure of symptom severity of depression. Lumateperone was generally safe and well-tolerated in these studies and adverse events were similar to those seen in prior studies of lumateperone in bipolar depression, MDD with mixed features, and schizophrenia. In Study 501 and Study 502, mean changes in key metabolic parameters, including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol, were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo. Lumateperone bipolar mania program: In the second quarter of 2024, we initiated two multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies evaluating lumateperone in the acute treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania). Lumateperone pediatric program: We expect to begin patient enrollment in two studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder in the second half of 2024. In addition, patient enrollment is ongoing in our double-blind, placebo-controlled study in bipolar depression and in our open-label safety study in schizophrenia and bipolar disorder in pediatric patients. Lumateperone Long Acting Injectable (LAI) program: We expect to commence clinical conduct in a Phase 1 single ascending dose study with several formulations shortly. The goal of the program is to develop LAI formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer. Other pipeline programs: ITI-1284-ODT-SL program: We have initiated patient enrollment in our Phase 2 clinical study evaluating ITI-1284 as adjunctive therapy to anti-anxiety medications in patients with generalized anxiety disorder (GAD). We expect to initiate a second Phase 2 GAD study, evaluating ITI-1284 as monotherapy, later this year. We have also initiated patient enrollment in a Phase 2 clinical study evaluating ITI-1284 as monotherapy in patients with psychosis associated with Alzheimer’s disease. We anticipate commencing patient enrollment in our Phase 2 program in agitation associated with Alzheimer’s disease shortly. Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors continues to advance in clinical development.Lenrispodun (ITI-214) Parkinson’s disease (PD) program: Our Phase 2 clinical trial is ongoing with topline results anticipated in 2025. The objective of this study is to evaluate improvements in motor symptoms in patients with PD. Changes in cognition and inflammatory biomarkers are also being assessed.ITI-1020 cancer immunotherapy program: Our Phase 1 single ascending dose study in healthy volunteers is ongoing. The objective of this study is to evaluate pharmacokinetics, safety, and tolerability of different doses of ITI-1020. ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and μ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder and pain. A multiple ascending dose study and a positron emission tomography (PET) study are both ongoing. ITI-1500 Non-Hallucinogenic Neuroplastogen Program: This program, previously referred to as our non-hallucinogenic psychedelic program, is focused on the development of novel neuroplastogens for the treatment of mood, anxiety, and other neuropsychiatric disorders without the hallucinogenic and cardiovascular effects of psychedelics. Our lead product candidate in this program, ITI-1549, continues to advance through IND enabling studies and is expected to enter human testing in 2025. Conference Call and Webcast Details The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. To attend the live conference call by phone, please use this registration link (https://register.vevent.com/register/BIa69e7f7949b74f8d9bc7846c268b0ecd). All participants must use the link to complete the online registration process in advance of the conference call. The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warning. About CAPLYTA (lumateperone) CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. Lumateperone is being studied for the treatment of major depressive disorder, and other psychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders. About Intra-Cellular Therapies Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com. Forward-Looking Statements This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our financial and operating performance, including our future revenues and expenses; our expectations regarding the commercialization of CAPLYTA; our plans to expand our sales force; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability or reporting of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or bipolar depression or in ongoing or future trials and other development activities; there is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine, Russia and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law. Contact: Intra-Cellular Therapies, Inc.Juan Sanchez, M.D. Vice President, Corporate Communications and Investor Relations646-440-9333 Burns McClellan, Inc.Cameron Radinoviccradinovic@burnsmc.com212-213-0006 INTRA-CELLULAR THERAPIES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands except share and per share amounts) (Unaudited) (1) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenues Product sales, net$161,276 $110,128 $306,119 $204,859 Grant revenue 112 664 135 1,239 Total revenues, net 161,388 110,792 306,254 206,098 Operating expenses: Cost of product sales 11,354 7,163 21,254 13,914 Selling, general and administrative 121,574 101,014 234,659 199,937 Research and development 56,183 49,794 99,016 87,818 Total operating expenses 189,111 157,971 354,929 301,669 Loss from operations (27,723) (47,179) (48,675) (95,571)Interest income 11,560 4,530 17,624 8,879 Loss before provision for income taxes (16,163) (42,649) (31,051) (86,692)Income tax expense (57) (135) (416) (145)Net loss$(16,220) $(42,784) $(31,467) $(86,837)Net loss per common share: Basic & Diluted$(0.16) $(0.45) $(0.31) $(0.91)Weighted average number of common shares: Basic & Diluted 103,723,007 95,948,063 100,299,141 95,543,626 (1) The condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. INTRA-CELLULAR THERAPIES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands except share and per share amounts) (Unaudited)(1) June 30,2024 December 31,2023 (unaudited) Assets Current assets: Cash and cash equivalents$693,306 $147,767 Investment securities, available-for-sale 329,601 350,174 Restricted cash 1,750 1,750 Accounts receivable, net 145,714 114,018 Inventory 20,082 11,647 Prepaid expenses and other current assets 73,798 42,443 Total current assets 1,264,251 667,799 Property and equipment, net 1,445 1,654 Right of use assets, net 14,507 12,928 Inventory, non-current 32,562 38,621 Other assets 7,739 7,293 Total assets$1,320,504 $728,295 Liabilities and stockholders’ equity Current liabilities: Accounts payable$17,548 $11,452 Accrued and other current liabilities 39,713 27,944 Accrued customer programs 77,971 53,173 Accrued employee benefits 22,372 27,364 Operating lease liabilities 4,171 3,612 Total current liabilities 161,775 123,545 Operating lease liabilities, non-current 14,117 13,326 Total liabilities 175,892 136,871 Stockholders’ equity: Common stock 11 10 Additional paid-in capital 2,793,896 2,208,470 Accumulated deficit (1,648,627) (1,617,160)Accumulated comprehensive (loss) income (668) 104 Total stockholders’ equity 1,144,612 591,424 Total liabilities and stockholders’ equity$1,320,504 $728,295 (1) The condensed consolidated balance sheets at June 30, 2024 and December 31, 2023 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

Clinical ResultPhase 2Phase 3Drug ApprovalImmunotherapy

07 Aug 2024

·www.biopharmadive.com

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Today, a brief rundown of news from Amgen and Servier, as well as updates from Merck & Co., Precigen and Sofinnova Investments that you may have missed.Speaking on a conference call Tuesday, executives at Amgen again fielded a long slate of analyst questions on the company's obesity drug development. But unlike in May, they had little new information to share about the progress of their chief candidate, called MariTide and now advancing through Phase 2 testing. Still, they reiterated their confidence that MariTide could be “differentiated“ from competitors like Novo Nordisk's Wegovy and Eli Lilly's Zepbound and, as a once-monthly shot, easier for patients to stay on and benefit from. Ned PagliaruloShares of Intra-Cellular Therapies were down almost 3% Wednesday despite an earnings reporta Mizuho Securities analyst described as “high quality.“ The neuroscience company recorded $161 million in revenue during the second quarter, almost all of which came from Caplyta, a drug for schizophrenia and bipolar disorder. Caplyta net sales were up 46% compared to the same three-month period from last year, beating Wall Street expectations. Intra-Cellular also announced the appointment of Sanjeev Narula, a Viatris veteran who will succeed the company's current CFO, Lawrence Hineline. Jacob BellThe Food and Drug Administration on Tuesday approved Servier's Voranigo for the treatment of glioma, a cancer of the brain and central nervous system. The drug, which was originally developed by Agios Pharmaceuticals, works by impeding the activity of two mutant enzymes, IDH1 and IDH2. The approval triggers a $200 million payment to Agios from Servier, which bought Agios' cancer drug business in 2021. Agios will also receive $905 million from Royalty Pharma, to which it sold its royalty rights on Voranigo earlier this year. Ned PagliaruloMerck & Co. and Daiichi Sankyo announced on Tuesday the addition of an experimental T cell engager to the broad alliancethe companies signed last year. Their partnership will now include MK-6070, which Merck acquired in its buyout of Harpoon Therapeutics in January. Daiichi Sankyo will pay Merck $170 million upfront and the companies will now jointly develop and sell MK-6070 globally, except in Japan. Merck and Daiichi Sankyosalliance had centered on three of the Japanese companys antibody-drug conjugates. Delilah AlvaradoCell and gene therapy developer Precigen Therapeutics on Wednesday said it would lay off 20% of its workforce as part of a strategic reprioritization. The restructuring is meant to help the company prepare for filing and potentially commercializing a gene therapy for recurrent respiratory papillomatosis, a rare condition involving benign growths in air passages. Precigen will also shut down a Belgium-based subsidiary called ActoBio. Delilah AlvaradoSofinnova Investments, a prominent backer of biotechnology companies, has brought on Maha Radhakrishnan as an executive partner. Radhakrishnan most recently served as chief medical officer at Biogen. Prior to that, she held leadership roles at Sanofi, overseeing medical strategy for products and development programs targeting diabetes and cardiovascular conditions. Jacob Bell '

Drug ApprovalExecutive ChangeCell TherapyAcquisition

100 Deals associated with Lumateperone Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11170	Lumateperone Tosylate	N05A	DB06077

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bipolar Disorder	US	Intra-Cellular Therapies, Inc.	17 Dec 2021
Schizophrenia	US	Intra-Cellular Therapies, Inc.	20 Dec 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bipolar I disorder	Phase 3	US	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	US	Intra-Cellular Therapies, Inc.	19 Jun 2024
Agitation in Dementia	Phase 3	US	Intra-Cellular Therapies, Inc.	29 Aug 2016
Alzheimer Disease	Phase 3	US	Intra-Cellular Therapies, Inc.	29 Aug 2016
Bipolar II disorder	Phase 3	US	Intra-Cellular Therapies, Inc.	15 Dec 2015
Depressive Disorder, Major	Phase 3	US	Intra-Cellular Therapies, Inc.	15 Dec 2015
Borderline Personality Disorder	Phase 2	US	Intra-Cellular Therapies, Inc.	10 May 2023
Autism Spectrum Disorder	Phase 1	US	Intra-Cellular Therapies, Inc.	10 May 2024
Schizoaffective disorder	Phase 1	US	Intra-Cellular Therapies, Inc.	12 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061706 (ITI-007-502, Company_Website) Manual	Phase 3	Depressive Disorder, Major Neoadjuvant	480	Lumateperone 42 mg	znwvioqvtb(ybsbbebbqy) = izqvonhmxy myromvezvt (cpobfxpzfp ) Met	Positive	18 Jun 2024
				Placebo	znwvioqvtb(ybsbbebbqy) = ngsfrmdkgo myromvezvt (cpobfxpzfp ) Met
NCT04985942 (Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	485	Lumateperone 42 mg	zevickdpts(jqtzuerrzs) = fmdyjzxbrp rwzafqqicg (btofhloamu ) Met	Positive	16 Apr 2024
Study 403 (GlobeNewswire) Manual	Not Applicable	Depressive Disorder, Major \| Bipolar Disorder	-	Lumateperone (MDD/bipolar depression)	sajebjaqpn(yyweaqekwm) = ccphhdhjvc aaegjctolc (vrgmcszprx, 0.67)	Positive	05 Dec 2023
Study 403 (GlobeNewswire) Manual	Not Applicable	Bipolar II disorder \| Bipolar I disorder \| Depressive Disorder, Major	-	Lumateperone 42mg (combined mixed features patient population of MDD and bipolar depression)	lxdgpmlgbb(ehetvyxnec) = kymnoqutrx ehzusfpnqy (mmnvvwumnt, 0.64)	Positive	05 Dec 2023
				Lumateperone 42mg (MDD with mixed features)	lxdgpmlgbb(ehetvyxnec) = taauedpegs ehzusfpnqy (mmnvvwumnt, 0.67)
NCT02600507 (CTgov)	Phase 3	Bipolar II disorder \| Depressive Disorder, Major	529	Lumateperone (ITI-007) (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	jpjmvrjzye(onfxtgnvrn) = mhywyvtxwz aldtrqwoiz (xyxiikzgrm, exxekpqwdf - iixobfkzyl) View more	-	17 May 2023
				Lumateperone (ITI-007) (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	jpjmvrjzye(onfxtgnvrn) = oevwekhndm aldtrqwoiz (xyxiikzgrm, gpwvaofjwn - gzsqldyklx) View more
NCT03249376 (Study 404, CTgov)	Phase 3	Depressive Disorder, Major	381	Lumateperone (Lumateperone)	ysalkbzakj(kehpfwcusu) = bklsowezwq ibhfcjazek (kkrvisszaw, bvcbhkntrc - xozilkbjdf) View more	-	03 Jun 2022
				Placebo (Placebo)	ysalkbzakj(kehpfwcusu) = yszzzlyyjl ibhfcjazek (kkrvisszaw, dxbmcpgfcb - dnyujlsbhi) View more
NCT03249376 (Pubmed \| Am J Psychiatry)	Phase 3	Bipolar II disorder \| Depressive Disorder, Major	381	Lumateperone 42 mg/day	grlsiajsng(lyolysktim) = Nausea occurred with lumateperone at a clinically meaningful greater rate than placebo ofmvtzknyc (bbyixslret ) View more	Positive	01 Dec 2021
NCT03817528 (CTgov)	Phase 2	Schizophrenia	4	ITI-007	epceppochw(easqafnhmj) = beyvqboagm gjqxlvsxxd (xwmtsdidxe, rqgquzysnv - peixnczguz) View more	-	02 Nov 2021
NCT02817906 (Study 201, CTgov)	Phase 3	Alzheimer Disease \| Agitation in Dementia	177	Placebo	azcisnujlm(dnrmlakejp) = osumphzqju ttcfywaiox (tebynuygdp, nbcwmwglng - cybofvrwem) View more	-	29 Jun 2021
NCT03249376 (Study 404, Pubmed) Manual	Phase 3	Depressive Disorder Adjuvant	377	Lumateperone	enupcaqujw(behcpjowsp): difference = -4.6 (95% CI, -6.34 to -2.83), P-Value = <0.0001	Positive	01 Apr 2021
				Placebo

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis