A Phase 1, Randomized, 2-way Crossover, Food-effect Study of Ecopipam Pharmacokinetics After Administration of the To Be Marketed Tablet in Healthy Subjects

Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.

Start Date05 Nov 2024

Sponsor / Collaborator

Emalex Biosciences, Inc.Startup

NCT06194864

/ CompletedPhase 1

A Phase 1, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Start Date18 Jan 2024

Sponsor / Collaborator

Emalex Biosciences, Inc.Startup

[+2]

NCT06021522

/ RecruitingPhase 3

A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).

Start Date16 Aug 2023

Sponsor / Collaborator

Emalex Biosciences, Inc.Startup

100 Clinical Results associated with Ecopipam

100 Translational Medicine associated with Ecopipam

100 Patents (Medical) associated with Ecopipam

230

Literatures (Medical) associated with Ecopipam

01 Jan 2025·Neuroscience Letters

Central administration of galanin-like peptide (GALP) causes short-term orexigenic effects in broilers: Mediatory role of NPY1 and D1 receptors

Article

Author: Haghbinnazarpak, Hadi ; Vazir, Bita ; Sanadgol, Elham ; Zendehdel, Morteza ; Rassouli, Ali

Studies conducted on mammalian models have indicated the role of galanin-like peptide (GALP) in appetite regulation. For the first time, the present study examines the effects of this peptide on feed consumption and behavioral changes, as well as its interaction with dopaminergic and neuropeptide Y (NPY) systems in broilers. In experiment 1, broilers were injected with GALP (0.5, 1, and 2 μg) and saline. In experiment 2, saline, NPY1 receptor antagonist (BIBO-3304), GALP (2 μg), and BIBO-3304 + GALP were administrated. Experiments 3-6 were identical to experiment 2, except that NPY2 receptor antagonist (BIIE 0246), NPY5 receptor antagonist (CGP 71683A), D1 receptor antagonist (SCH39166), and D2 receptor antagonist (L-741,626) were injected instead of BIBO-3304. After that, cumulative meal consumption was recorded for 2 h. Also, behavioral changes in the broilers receiving GALP (0.5, 1, and 2 μg) were monitored for thirty minutes after infusion. Following the administration of GALP (1 and 2 μg), food intake and the number of feeding and exploratory pecks of chicks increased (P < 0.05), while other behaviors did not change significantly (P ≥ 0.05). Co-infusion of BIBO-3304 + GALP suppressed the orexigenic effect of GALP (P < 0.05). Infusion of BIIE 0246, CGP 71683A, and L-741,626 with GALP, had no significant effect on GALP-induced hyperphagia (P ≥ 0.05). However, the orexigenic effects of GALP were stimulated following the co-administration of SCH39166A + GALP (P < 0.05). These findings indicate that NPY1 and D1 receptors can mediate GALP-induced hyperphagia in broilers.

01 Dec 2024·The Journal of Pharmacology and Experimental Therapeutics

Dopamine D1-Like Receptor-Mediated Insurmountable Blockade of the Reinforcing Effects of Cocaine in Rats

Article

Author: Soto, Paul L ; Hiranita, Takato ; Katz, Jonathan L ; Soto, Paul L. ; Katz, Jonathan L.

Previous studies indicated differing effects of dopamine D₁-like and D₂-like receptor (D₁R and D₂R, respectively) agonists on cocaine self-administration. Leftward shifts by D₂R agonists in the cocaine self-administration dose-effect function contrast with decreases by D₁R agonists in maximal cocaine self-administration without rightward or leftward displacement. Whether the effects of the D₁R agonists are due to actions at D₁Rs has not been determined, possibly due to the difficulty in separating the blockade by a D₁R antagonist of the effects of the D₁R agonists and those of cocaine. In the present study, pretreatment with the D₁R agonists R(+)-SKF-81297 (0.1-1.0 mg/kg) and (±)-SKF-82958 (0.032-0.32 mg/kg) dose-dependently decreased maximal cocaine self-administration at doses below those affecting food-reinforced responding. In contrast, pretreatment with the D₂R agonists R(-)-NPA (0.001-0.01 mg/kg) and (-)-quinpirole (0.01-0.1 mg/kg) dose-dependently left-shifted the cocaine self-administration dose-effect function. The decreases by D₁R agonists in maximal cocaine self-administration were dose-dependently antagonized by the D₁R antagonist SCH-39166 at doses that alone had no effects on cocaine self-administration. Doses of SCH-39166 that blocked the effects of the D₁R agonists on cocaine self-administration were like those that shifted self-administration of D₁R agonists to the right but had no effects on self-administration of D₂R agonists. Self-administration of the D₂R agonists was dose-dependently shifted to the right by the preferential D₂R antagonist L-741,626 but not by SCH-39166. These results demonstrate that the decreases by the D₁R agonists in cocaine self-administration are selectively D₁R-mediated and support findings suggesting fundamentally distinct roles of the D₁Rs and D₂Rs in cocaine reinforcement. SIGNIFICANCE STATEMENT: Dopamine D₁-like (D₁R) agonists decrease maximal cocaine self-administration, whereas D₂-like (D₂R) agonists shift the cocaine self-administration dose-effect function leftward, with mechanisms for those different effects unclear. The present study demonstrates blockade by the selective D₁R antagonist SCH-39166 of D1R-mediated decreases in maximal cocaine self-administration at doses that blocked other D₁R-mediated effects but not effects of cocaine, suggesting fundamentally distinct roles of the dopamine D₁-like and D₂-like receptors in cocaine reinforcement and development of D₁R agonists as potential treatments for cocaine use disorder.

01 Oct 2024·Psychopharmacology

Pharmacological characterization of sex differences in the effects of dopaminergic drugs on effort-based decision making in rats

Article

Author: Martinez-Verdu, Andrea ; Olivares-Garcia, Regulo ; Beard, Kathryn R ; Correa, Merce ; Srynath, Sonia ; Ecevitoglu, Alev ; Meka, Nicolette ; Salamone, John D ; Edelstein, Gayle A

RATIONALEMotivational dysfunctions related to effort exertion are common in psychiatric disorders. Dopamine systems regulate exertion of effort and effort-based choice in humans and rodents.OBJECTIVESPrevious rodent studies mainly employed male rats, and it is imperative to conduct studies in male and female rats.METHODSThe present studies compared the effort-related effects of IP injections of the dopamine antagonists ecopipam and haloperidol, and the vesicular monoamine transport-2 inhibitor tetrabenazine (TBZ), in male and female rats using the fixed ratio 5/chow feeding choice task.RESULTSEcopipam (0.05-0.2 mg/kg) and haloperidol (0.05-0.15 mg/kg) induced a low-effort bias, decreasing lever pressing and increasing chow intake in males and females in the same dose range. With lever pressing, there was a modest but significant dose x sex interaction after ecopipam injection, but there was no significant interaction after administration of haloperidol. In the first study with TBZ (0.25-1.0 mg/kg), there was a robust sex difference. TBZ shifted choice from lever pressing to chow intake in male rats, but was ineffective in females. In a second experiment, 2.0 mg/kg affected choice behavior in both males and females. TBZ increased accumbens c-Fos immunoreactivity in a sex-dependent manner, with males significantly increasing at 1.0 mg/kg, while females showed augmented immunoreactivity at 2.0 mg/kg.CONCLUSIONSThe neural and behavioral effects of TBZ differed across sexes, emphasizing the importance of conducting studies in male and female rats. This research has implications for understanding the effort-related motivational dysfunctions seen in psychopathology.

News (Medical) associated with Ecopipam

24 Jul 2024

·www.fiercebiotech.com

Tourette's biotech Asarina to wind down after outreach to 200 companies fails to produce a partner

Asarina Pharma revealed in April 2023 that its Tourette syndrome therapy reduced tic severity at 12 weeks by 28%. After reaching out to more than 200 companies to partner a Tourette syndrome therapy that showed the ability to beat standard of care last year, Asarina Pharma has come up empty and will fold. The company asked shareholders to vote to liquidate in a notice posted Monday, the culmination of more than a year of effort to find a savior for the treatment called sepranolone. The Swedish company revealed in April 2023 that the therapy reduced tic severity at 12 weeks by 28% according to a common rating scale of disease severity called the Yale Global Tic Severity Scale (YGTSS), compared to 12.6% in patients who received standard of care. The phase 2a study also hit key secondary endpoints, including improving quality of life, and there were no systemic side effects observed. The open-label study randomized 28 patients to receive the experimental medicine or standard of care, with 17 receiving sepranolone. But those results were not enough to secure a partner, despite a grand effort from the Asarina team. In a proposal to liquidate issued July 18, the company said 200 parties had been contacted with 20 entities expressing interest in a potential in-licensing or acquisition deal. Several went as far as conducting due diligence on the clinical data. But none of those talks resulted in an offer. Asarina also explored a capital raise “but unfortunately has been forced to conclude that conditions for this are missing,” according to the notice. The company currently has equity of -635,000 Swedish kronor (-$59,000). “In light of the company's financial and commercial situation … the board of directors sees no alternative but to propose a winding up of the company's operations in an orderly manner, which can be done through a liquidation,” the notice explained. A meeting will be held in August to consider the plan to wrap up, with a liquidation date slated for Dec. 1. ”After more than 15 years of R&D development and more than 15 months of partnering activities, it is disappointing that we have not been able to find a new home for sepranolone. We still believe that the compound has the potential to be an effective drug for Tourette's syndrome and other neurological disorders,” said board Chairman Paul De Potocki in a statement. While drug development in Tourette syndrome has not seen a lot of action in recent years, at least one biotech is working on it. Emalex Biosciences published phase 2b data last year for a candidate called ecopipam showing a 30% reduction on the YGTSS. The company did not detail placebo results but said the 30% value represented a significant reduction in the total number of tics compared to placebo. Ecopipam also had a different safety profile, showing adverse events including headache in 15% of recipients, insomnia in 15%, fatigue in 8% and drowsiness in 8%. Emalex raised a massive $250 million in series D funds in 2022, which was to be used to fund a phase 3 test. That trial is now underway as of March 2023.

Phase 2Clinical ResultAcquisition

05 Oct 2023

·www.biospace.com

Emalex Biosciences Releases Results of 12-Month Open-Label Extension Study for Tourette Syndrome Candidate

Long-term safety data collected in pediatric patients treated with investigational drug ecopipam; durable treatment effect reported with no evidence of tachyphylaxis CHICAGO--(BUSINESS WIRE)-- An open-label extension study of 121 pediatric patients with Tourette syndrome evaluated the safety pro the investigational drug ecopipam for up to 12-months of treatment. No new safety concerns were identified based on an evaluation of adverse events, physical exams, vital signs, laboratory results and safety scales, according to Emalex Biosciences. A durable effect was also observed over the course of the study based on evaluation of the patients’ motor and vocal tics, which were assessed every three months. The findings were first presented at the International Congress of Parkinson’s Disease and Movement Disorder Society in Copenhagen and will be highlighted at the Child Neurology Society Annual Meeting this week in Vancouver. Patients in the open-label study previously completed a Phase 2b clinical trial involving more than 150 children and adolescents that found ecopipam significantly reduced the total number of motor and vocal tics compared to placebo, according to a study published in the journal Pediatrics. In this open-label study, ecopipam was generally well tolerated, with 33.1% (40/121) of patients reporting treatment-related adverse reactions (ARs). The most common ARs were anxiety (6.6%), insomnia (5.8%), and somnolence (5.8%). One patient experienced a serious adverse reaction (obsessive thoughts) and 11.6% (14/121) of patients discontinued the study due to adverse events. In addition, patients did not have observable evidence of excessive weight gain or metabolic side effects commonly reported with antipsychotic agents, which are often used to treat patients with Tourette syndrome. Ecopipam is a first-in-class dopamine-1 receptor antagonist. The antipsychotic agents currently approved to treat Tourette syndrome target the dopamine-2 receptor. Ecopipam is the lead candidate for Emalex Biosciences, a clinical-stage biopharmaceutical company founded by Paragon Biosciences. Emalex is currently conducting a Phase 3 clinical trial of ecopipam for the treatment of Tourette syndrome at more than 90 sites in North America and Europe. Tourette syndrome is a chronic, childhood-onset neurodevelopmental disorder characterized by motor and vocal tics. The condition is associated with both increased mortality and significant morbidity. In the majority of individuals, Tourette syndrome substantially impacts day-to-day physical and social function. “The fact that most patients who completed the Phase 2b study asked to participate in the open-label extension points to the unmet medical needs for people with Tourette syndrome. The 12-month data supports the continued development of ecopipam as a first-in-class novel therapy for children and adolescents with Tourette syndrome,” said Emalex Biosciences Chief Medical Officer Frederick Munschauer, MD. About Ecopipam Emalex’s first-in-class development candidate ecopipam, a novel investigational compound that is being studied as a potential treatment for certain central nervous system disorders, blocks the actions of the neurotransmitter dopamine at the D1 receptor. Dopamine is a neurotransmitter in the central nervous system, and its receptors have been classified into two “families” based on their genetic structure: “D1” (including subtypes D1 and D5) and “D2” (including subtypes D2, D3, and D4). D1 receptor super-sensitivity may be a mechanism for the repetitive and compulsive behaviors associated with Tourette syndrome. Currently approved therapies for the treatment of Tourette syndrome act at D2 receptors. Ecopipam has been shown to be generally well tolerated in clinical trials conducted to date and has received Orphan Drug and Fast Track designation from the FDA for the treatment of patients with Tourette syndrome. Adverse events affecting primarily the central nervous system have been reported in clinical trials conducted to date, including headache, fatigue, somnolence, insomnia, restlessness, anxiety, depression and rarely, suicidal ideation. About Emalex Biosciences Emalex Biosciences was created by Paragon Biosciences to develop new treatments for central nervous system disorders. Emalex is in late-stage development of a new class of drug targeting the D1 receptor for patients with Tourette syndrome and other conditions that have limited treatment options. Visit to learn more. About Paragon Biosciences, LLC Paragon Biosciences is a global life science leader that creates, builds and funds innovative biology-based companies in three key areas: cell and gene therapy, biology engineering and advanced biotechnology. Our portfolio companies use biology to accelerate scientific breakthroughs that solve some of society’s most challenging problems. Learn more at .

Phase 2Orphan DrugFast TrackClinical ResultPhase 3

01 Mar 2023

·www.prnewswire.com

Emalex Biosciences Announces First Patient Dosed in Phase 3 Trial of Ecopipam for Tourette Syndrome

Enrolled patients will receive medication for up to 24 weeks; 90 sites planned for North America and Europe CHICAGO, March 1, 2023 /PRNewswire/ -- Emalex Biosciences announced that the first patient was dosed in its Phase 3 clinical trial evaluating ecopipam for the treatment of Tourette Syndrome. Continue Reading Participants in the trial receive ecopipam for 12 weeks in the open-label phase of the study. Those with at least a 25% reduction in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at both week 8 and 12 will be randomized to continue on ecopipam or placebo in the double-blind phase of the study until they relapse, up to an additional 12 weeks. Efficacy will be assessed as the difference in time-to-relapse between groups. Participants in the trial receive ecopipam for 12 weeks in the open-label phase of the study. Tweet this "Tourette Syndrome is a serious condition for which there is significant unmet need," said Amanda Talty, Tourette Association of America president and CEO. "Currently, the two classes of medicines commonly used to treat Tourette can have a number of concerning side effects. We are happy to see the progress of additional studies being conducted to test new treatment alternatives for our community." Emalex closed an upsized and oversubscribed $250 million Series D round led by Bain Capital Life Sciences in November to fund the Phase 3 trial and potential commercialization of ecopipam. The trial is expected to enroll more than 200 patients across 90 sites in North America and Europe. Ecopipam is a first-in-class dopamine-1 receptor antagonist. The antipsychotic agents currently approved to treat Tourette syndrome target the dopamine-2 receptor and are associated with serious side effects. Patients enrolled in the Phase 2b D1AMOND study did not have observable evidence of adverse movements, excessive weight gain, or the metabolic side effects commonly reported with antipsychotic agents. The most frequent ecopipam-related adverse events in the study were headache (9.2%), fatigue (6.6%), somnolence (6.6%), insomnia (5.3%), and restlessness (5.3%). Tourette Syndrome is a chronic, childhood-onset neurodevelopmental disorder characterized by motor and vocal tics. The condition is associated with both increased mortality and significant morbidity. In the majority of individuals, Tourette Syndrome substantially impacts day-to-day physical and social function. Principal investigator Donald Gilbert, MD, a movement disorders specialist at the Cincinnati Children's Hospital, noted patients' tics often cause pain and injury in addition to social stigma and emotional distress. "My patients have an urgent need for safer and more effective treatments. Tourette interferes with daily activities and commonly has negative impacts on mental and emotional health. For children and teens, Tourette can affect school performance and social development, which has lifelong consequences," Dr. Gilbert said. About Ecopipam Emalex's first-in-class development candidate, ecopipam, is a novel investigational compound that is being studied as a potential treatment for certain central nervous system disorders. Ecopipam blocks the actions of the neurotransmitter dopamine at the D1 receptor. Dopamine is a neurotransmitter in the central nervous system, and its receptors have been classified into two "families" based on their genetic structure: "D1" (including subtypes D1 and D5) and "D2" (including subtypes D2, D3, and D4). D1 receptor super-sensitivity may be a mechanism for the repetitive and compulsive behaviors associated with Tourette syndrome. Currently approved therapies for the treatment of Tourette syndrome act at D2 receptors. Ecopipam has been shown to be generally well tolerated in clinical trials conducted to date and has received Orphan Drug and Fast Track designation from the FDA. Adverse events affecting primarily the central nervous system have been reported in clinical trials conducted to date include headache, fatigue, somnolence, insomnia, restlessness, anxiety, depression and rarely, suicidal ideation. Further information can be found on clinicaltrials.gov. About Emalex Biosciences Emalex Biosciences was created by Paragon Biosciences to develop new treatments for central nervous system disorders. Emalex is in late-stage development of a new class of drug targeting the D1 receptor for patients with Tourette syndrome and other conditions that have limited treatment options. Visit to learn more About Paragon Biosciences Paragon Biosciences is a global life science leader that creates, builds and funds innovative biology-based companies in three key areas: cell and gene therapy, biology engineering and advanced biotechnology. Our portfolio companies use biology to accelerate scientific breakthroughs that solve some of society's most challenging problems. Learn more at . Media Contact: Sheridan Chaney 312.847.1323 [email protected] SOURCE Emalex Biosciences

Phase 3Orphan DrugPhase 2Fast Track

100 Deals associated with Ecopipam

External Link

KEGG	Wiki	ATC	Drug Bank
D03937	Ecopipam	-	DB12273

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tourette Syndrome	Phase 3	FR	Emalex Biosciences, Inc.Startup	31 Jan 2023
Tourette Syndrome	Phase 3	RO	Emalex Biosciences, Inc.Startup	31 Jan 2023
Tourette Syndrome	Phase 3	DK	Emalex Biosciences, Inc.Startup	31 Jan 2023
Tourette Syndrome	Phase 3	BG	Emalex Biosciences, Inc.Startup	31 Jan 2023
Lesch-Nyhan Syndrome	Phase 3	-	Merck Sharp & Dohme Corp.	-
Self-Injurious Behavior	Discovery	US	Emalex Biosciences, Inc.Startup	01 Dec 2012
Self-Injurious Behavior	Discovery	ES	Emalex Biosciences, Inc.Startup	01 Dec 2012
Self-Injurious Behavior	Discovery	US	Psyadon Pharmaceuticals, Inc.	01 Dec 2012
Self-Injurious Behavior	Discovery	ES	Psyadon Pharmaceuticals, Inc.	01 Dec 2012
Obesity	Discovery	US	Schering-Plough Corp.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications Manual	Phase 2	Tourette Syndrome	-	Ecopipam	(whhmabfpdq) = ioutnxbher chedltsruf (ficjttkvur ) View more	Positive	05 Oct 2023
NCT04007991 (D1AMOND, CTgov)	Phase 2	Tourette Syndrome	153	Ecopipam (Ecopipam HCI 2 mg/kg/Day)	kwhczysrak(sitnttyzcg) = sczrkfnzke vuievchszd (uzheimjorg, kruyowcjtn - vqvycggjyv) View more	-	04 Oct 2023
NCT04007991 (D1AMOND, CTgov)	Phase 2	Tourette Syndrome	153	Placebo (Placebo)	kwhczysrak(sitnttyzcg) = lpvfybyjgq vuievchszd (uzheimjorg, wloxruzmqs - rvitttijqc) View more	-	04 Oct 2023
MDS2022	Phase 2	Tourette Syndrome	153	Ecopipam	(qkmknmclim): LS mean [SE] difference = -3.4 (95% CI, -6.1 to -0.8), P-Value = 0.011 View more	Positive	15 Sep 2022
MDS2022	Phase 2	Tourette Syndrome	153	Placebo		Positive	15 Sep 2022
MDS2021	Phase 2	Tourette Syndrome	26	Ecopipam	(jvaelczkps) = jwsvnorwpc ttgvbxppfm (qshpoowxxc )	Positive	17 Sep 2021
MDS2019	Not Applicable	Restless Legs Syndrome	10	Ecopipam	njxrmpddsn(gzmxbgaowx) = Tolerability was very good zsyjhguawx (fgzuzbpefx ) View more	Positive	22 Sep 2019
MDS2019	Not Applicable	Restless Legs Syndrome	10	Placebo		Positive	22 Sep 2019
NCT01065558 (Pubmed \| Mol Genet Metab) Manual	Phase 1	Lesch-Nyhan Syndrome	5	ecopipam	(tznolgaqvy) = sedation being the most common dose-limiting event xtipgsylmd (aihrqkyjvp )	Positive	01 Apr 2016
NCT01751802 (CTgov)	Phase 3	Lesch-Nyhan Syndrome \| Self-Injurious Behavior	9	Ecopipam (Ecopipam)	wadirbqlpj(wcoxoahlzr) = qzphklcabe iqmijcldfd (qlqmbhvnbj, ryoqkcloxv - fbujnbmpoi) View more	-	08 Oct 2015
NCT01751802 (CTgov)	Phase 3	Lesch-Nyhan Syndrome \| Self-Injurious Behavior	9	Placebo (Placebo)	wadirbqlpj(wcoxoahlzr) = djuvalbtao iqmijcldfd (qlqmbhvnbj, xorifgptfv - uyiuymewxc) View more	-	08 Oct 2015
NCT01244633 (CTgov)	Phase 1/2	Tourette Syndrome	18	Ecopipam	(vufvcggxpc) = zrlbtylkwf romrqvvkzu (tnccruphop, dzkpsqvmsm - rifwfxzbdq) View more	-	29 Sep 2015
NCT02909088 (Pubmed \| Clin Neuropharmacol)	Phase 2/3	Tourette Syndrome	18	Ecopipam 50 mg	wboohchcqk(nmzbxasgfy) = 22% hqbaygreqd (dnuvirkgep ) View more	-	01 Jan 2014
P02.058 (AAN2013)	Not Applicable	Tourette Syndrome	15	Ecopipam 50 mg	(ozolvvapob) = Three patients each reported fatigue xwgjhjbryg (uinoyqhems ) View more	Positive	12 Feb 2013

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