Last update 18 Dec 2024
KB-3061
Last update 18 Dec 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms BHV-7000, BPN-25203, KB 3061 + [1] |
Target |
Mechanism KCNQ (Kv7) agonists(KCNQ (Kv7) potassium channel agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 2/3 |
First Approval Date- |
Regulation- |
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Related
9
Clinical Trials associated with KB-3061- BHV2100-112
Start Date07 Oct 2024 |
Sponsor / Collaborator |
A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Major Depressive Disorder (MDD)
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).
Start Date01 Aug 2024 |
Sponsor / Collaborator |
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Start Date30 Jul 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with KB-3061
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100 Translational Medicine associated with KB-3061
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100 Patents (Medical) associated with KB-3061
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1
Literatures (Medical) associated with KB-306101 Oct 2024·EPILEPSIA
Progress report on new medications for seizures and epilepsy: A summary of the 17th Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII). I. Drugs in preclinical and early clinical development
Article
Author: White, H. Steve ; Johannessen, Svein I. ; Perucca, Emilio ; Tomson, Torbjörn ; Koepp, Matthias J. ; Bialer, Meir ; Perucca, Piero
Abstract:
For >30 years, the Eilat Conference on New Antiepileptic Drugs and Devices has provided a forum for the discussion of advances in the development of new therapies for seizures and epilepsy. The EILAT XVII conference took place in Madrid, Spain, on May 5–8, 2024. Participants included basic scientists and clinical investigators from industry and academia, other health care professionals, and representatives from lay organizations. We summarize in this article information on treatments in preclinical and in early clinical development discussed at the conference. These include AMT‐260, a gene therapy designed to downregulate the expression of Glu2K subunits of kainate receptors, in development for the treatment of drug‐resistant seizures associated with mesial temporal sclerosis; BHV‐7000, a selective activator of heteromeric Kv7.2/7.3 potassium channels, in development for the treatment of focal epilepsy; ETX101, a recombinant adeno‐associated virus serotype 9 designed to increase NaV1.1 channel density in inhibitory γ‐aminobutyric acidergic (GABAergic) neurons, in development for the treatment of SCN1A‐positive Dravet syndrome; GAO‐3‐02, a compound structurally related to synaptamide, which exerts antiseizure activity at least in part through an action on cannabinoid type 2 receptors; LRP‐661, a structural analogue of cannabidiol, in development for the treatment of seizures associated with Lennox–Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex; OV329, a selective inactivator of GABA aminotransferase, in development for the treatment of drug‐resistant seizures; PRAX‐628, a functionally selective potent sodium channel modulator with preference for the hyperexcitable state of sodium channels, in development for the treatment of focal seizures; RAP‐219, a selective negative allosteric modulator of transmembrane α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptor regulatory protein γ‐8, in development for the treatment of focal seizures; and rozanolixizumab, a humanized anti‐neonatal Fc receptor monoclonal antibody, in development for the treatment of LGI1 autoimmune encephalitis. Treatments in more advanced development are summarized in Part II of this report.
27
News (Medical) associated with KB-306116 Dec 2024
BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the MAD.
Subcutaneous BHV-1300 achieved rapid and progressive lowering of IgG within hours of each weekly dose administration, and pharmacodynamic effects were sustained relative to baseline over the four-week period. The optimized subcutaneous formulation also showed substantially less inter-patient variability in the MAD compared to the previously reported intravenously administered BHV-1300.
BHV-1300 has been safe and well tolerated across the ongoing Phase 1 without any dose limiting toxicity to date. All AEs have been mild, with no SAEs or discontinuations related to study drug. Dose escalation continues with the optimized subcutaneous formulation to explore the full range of IgG reductions possible with BHV-1300. Additional Phase 1 data will be presented upon completion of the remaining subcutaneous cohorts in 1Q25.
Laboratory data from the MAD confirm a differentiated safety profile compared to competitor agents as BHV-1300 has had no clinically significant reductions in albumin, liver function test abnormalities or increases in cholesterol at week 4 relative to baseline. Further enhancing the competitive safety profile, BHV-1300 was rationally designed to spare IgG3 with plasma IgG3 levels over the course of the MAD preserved through the end of study week 4 to allow for healthy immune effector functioning.
Submitted new drug application (NDA) to US FDA for troriluzole in spinocerebellar ataxia (SCA), following completion of pre-NDA meeting in 4Q 2024. Troriluzole has Orphan Drug and Fast-Track designations and qualifies for potential Priority Review.
Announced completion of enrollment during 4Q 2024 in the BHV-7000 pivotal 3-week, Phase 2/3 bipolar trial, several months ahead of timelines.
Expanded and advanced the molecular degraders of extracellular proteins (MoDE) clinical program to include next-generation autoantibody specific degraders that selectively remove pathogenic antibodies while preserving healthy immune functioning, with regulatory acceptance of 3 novel drug candidate INDs and/or CTAs in 4Q24:
IgA nephropathy: Initiated Phase 1 dosing with BHV-1400, a novel IgAN investigational therapy designed to selectively degrade pathogenic galactose deficient IgA1 (Gd-IgA1) while sparing normal IgA. In addition to rapid and sustained lowering of Gd-IgA1, BHV-1400 is expected to result in less potential for respiratory, mucosal or central nervous system infections compared to broader IgA lowering or immunosuppressive strategies in development by competitors.
Autoimmune cardiomyopathy: Initiated Phase 1 dosing with BHV-1600, a novel investigational therapy designed to selectively degrade b1 adrenergic receptor (b1AR) autoantibodies. Biohaven also completed an INTERACT meeting with FDA regarding BHV-1600 in 4Q 2024 and gained alignment for the study design to pursue an accelerated approval pathway in peripartum cardiomyopathy (PPCM), a rare autoimmune life-threatening disease with no approved therapy.
IgG mediated diseases: IND opened for BHV-1310, an optimized and selective IgG1, IgG2, and IgG4 degrader in 4Q 2024 with first dosing planned for 1Q 2025.
Entered into an agreement with Ypsomed to develop and manufacture BHV-1300 in an easy-to-use, autoinjector for self-administration. Ypsomed is a leading provider of autoinjector technology used in commercialized products for convenient patient use.
The Ypsomed device is expected to be used across all MoDE programs through development and commercial use, derisking this aspect of the development program as well as providing seamless transitions and allowing for significant data generation on the device in advance of future NDA filings.
NEW HAVEN, Conn., Dec. 16, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today highlighted the achievement of several clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins (MoDE™) platform as well as its glutamate modulation and ion channel programs.
Figure 1: BHV-1300 easy-to-use autoinjector for pivotal trials in 2025, developed and manufactured in collaboration with Ypsomed. Ypsomed, a Swiss device maker and global leader in the development of innovative injection systems, is well-known for its design, development and production of user-friendly injectors for self-medication in various diseases including the treatment of metabolic disorders. This device is expected to be used across all MoDE programs through development and commercialization, providing seamless transitions and allowing for significant data generation on the device in advance of future NDA filings.
Figure 2: (A) IgA nephropathy is caused by excess production of galactose deficient IgA1 and deposition in the renal glomerulus, setting off an inflammatory cascade and renal damage.
Figure 2: (B) BHV-1400 degrades galactose deficient IgA1 (red) in vivo in preclinical models. With BHV-1400 administration compared to vehicle administration, galactose deficient IgA1 clears from the renal glomerulus (inset) over hours. BHV-1400 was designed with precision to remove the pathogenic driver of IgA nephropathy and preserve components of the immune system crucial to fighting infections, such as meningitis.
Figure 3: Autoantibodies target the b1-adrenergic receptor (b1AR) to cause cardiac dilation and heart failure.1 BHV-1600 selectively removes autoantibodies to b1AR, and has been dosed in humans, with recent FDA alignment on a clinical development program to most efficiently deliver a potentially transformative therapeutic to patients with peripartum cardiomyopathy.
Subcutaneously administered BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the ongoing multiple ascending dose (MAD) study. Subcutaneous BHV-1300 achieved progressive reduction in IgG within hours of each weekly dose administration in the MAD, and pharmacodynamic effects were sustained relative to baseline over the four-week study period. BHV-1300 has been safe and well-tolerated across the Phase 1 study. There were no clinically significant effects on albumin or liver function, and no increases in cholesterol were noted. Further enhancing the competitive safety profile and as intentionally designed, plasma IgG3 levels were preserved through the end of study week 4 to allow for healthy immune effector functioning. All AEs were mild, any drug-related AE resolved, and there were no discontinuations due to study drug related AEs. The optimized subcutaneous formulation in the MAD also showed substantially less inter-patient variability compared to previously reported intravenous BHV-1300. Escalating dose level cohorts of subcutaneous BHV-1300 are ongoing to explore the full range of IgG reductions possible with BHV-1300 for a wide range of future disease indications.
Tova Gardin MD, MPP, Biohaven's Chief Translational Officer, commented, "The results of subcutaneously delivered BHV-1300 from the first and lowest MAD dose cohort represent a monumental step forward for our MoDE platform with deep and rapid reduction in targeted IgG. Our results highlight the selectivity and precision of BHV-1300 in potentially treating IgG mediated immune diseases while the regulatory acceptance of three next generation degraders showcases the future of the MoDE technology in autoantibody disease. With speed, selectivity, and depth of lowering, BHV-1300 has the potential to transform the treatment of autoimmune disease and has paved the way for rapid innovation across the degrader platform. With the mechanistic validation of BHV-1300 and performance of the optimized subcutaneous formulation in Phase 1, we have begun the manufacturing of a convenient autoinjector that will further differentiate our approach in the clinic. The early autoinjector development to ensure a commercial ready, patient-administered device for BHV-1300 was important to derisking this aspect of our MoDE development program."
Biohaven licensed the MoDE technology from Yale University with high potential differentiation for the treatment of autoimmune diseases, including rapid degradation of targets within hours, deep reductions that can be titrated by dose level and frequency, simple-to-use patient administration, excellent tolerability without deleterious effects on albumin or cholesterol, and the flexibility to be used in conjunction with Fc-containing biologics (unlike other IgG lowering agents). Additionally, BHV-1300 is unique with its selective removal of targeted IgG (IgG1, IgG2 and IgG4 over IgG3). IgG3 plays a critical role in the immune response and in activating effector functions crucial for combating bacteria, parasites, and viruses. BHV-1300 was designed to spare IgG3 to avoid the broad immunosuppression associated with other IgG lowering approaches and to allow for an immune response to combat potential infections while delivering therapeutic actions in autoimmune disease. Results of the ongoing Phase 1 trial validate the selectivity of BHV-1300 and the adaptability of the platform to engage targets of interest with precision.
In addition to the new Phase 1 data with BHV-1300, Biohaven also announced regulatory acceptance of three INDs and/or CTAs for its next-generation MoDE molecules to target other immune mediated diseases. Two of these novel MoDEs, BHV-1400 and BHV-1600, represent the platform's first autoantibody specific degraders, sparing the body's healthy antibodies (IgG, IgA, etc.) to function normally while clearing disease-causing antibodies.
Dosing in humans has been initiated for BHV-1400, a novel IgA nephropathy (IgAN) investigational therapy designed to selectively degrade galactose deficient IgA1 (Gd-IgA1) without immunosuppression. IgAN is a rare disease affecting approximately 60,000 individuals in the United States. It is often diagnosed in the second or third decade of life, progresses over decades, and can result in kidney failure leading to the need for hemodialysis. Approved therapies broadly suppress the immune system or target the downstream consequences of immune damage without targeting the autoimmune cause of disease. For a disease which is diagnosed in young adults and treatment may be required over the lifespan, BHV-1400 is highly differentiated, engineered to clear the pathogenic nidus of disease, Gd-IgA1, and preserve the individual's immunoglobulins (IgG, IgA, IgE, IgM), immune cells, and complement system (Figure 2). Thus, BHV-1400 is expected to result in less potential for respiratory, mucosal or central nervous system infections compared to broader IgA lowering or immunosuppressive strategies in development. Additionally, IgAN clinical trials have a well-established pathway for accelerated approval.
Biohaven also initiated dosing in humans with BHV-1600 in 4Q 2024. BHV-1600 is a MoDE engineered to rapidly degrade pathogenic autoantibodies to the b1-adrenergic receptor (b1AR). BHV-1600 is the first rationally designed investigative treatment in development for peripartum cardiomyopathy (PPCM), a rare type of heart failure that occurs during pregnancy or soon after birth that has no currently approved therapy. In b1AR autoantibody-driven cardiomyopathy, autoantibodies bind b1AR and induce cardiomyocyte toxicity and heart failure (Figure 3).1 PPCM affects mothers at an incredibly vulnerable period: previously healthy, individuals with PPCM develop profound heart failure, struggling with new symptoms as their child experiences its first days and often first years of life. Without disease-specific therapies, women with PPCM can develop heart failure and may emergently require left ventricular assistive devices or heart transplant. Given PPCM is a life-threatening disease with no current treatment and the potential for BHV-1600 to rapidly degrade pathogenic b1AR autoantibodies, Biohaven completed an INTERACT meeting with the FDA in 4Q 2024 and gained alignment on a clinical development program to pursue an accelerated approval pathway for BHV-1600 in PPCM.
An IND has also been accepted for BHV-1310, an optimized and selective IgG1, IgG2, and IgG4 degrader. Dosing is expected in humans in 1Q 2025.
In addition to key updates in the MoDE clinical development program, Biohaven also announced critically important advances related to its late-stage glutamate and ion channel platforms. A new drug application (NDA) was submitted to the US FDA for troriluzole in the treatment of all genotypes of spinocerebellar ataxia (SCA), following the completion of a pre-NDA meeting in 4Q 2024. Troriluzole was previously granted Orphan Drug and Fast-Track designations by FDA, and qualifies for potential Priority Review. Biohaven recently reported positive topline pivotal results in SCA in September 2024, demonstrating that troriluzole slowed disease progression by 50-70% over the 3-year study period. SCA is a rare, life-threatening, progressively debilitating neurodegenerative disease that affects approximately 15,000 people in the US, and 24,000 in Europe and the United Kingdom. Troriluzole has been safe and well-tolerated in over 8 years of clinical trial experience. There are no FDA approved treatments for SCA and troriluzole is the first investigational agent to show disease slowing in its clinical development program.
Biohaven further announced the completion of enrollment in a pivotal BHV-7000 Phase 2/3 trial in bipolar disorder in 4Q 2024. BHV-7000 is a selective activator of Kv7 potassium channels that offers a novel and compelling mechanism of action for the treatment of bipolar disorder and an excellent tolerability at all doses evaluated in previous studies without the central nervous system adverse effects, such as somnolence and other CNS-related effects, that typically limit the use of other mood stabilizing medications. The trial completed enrollment several months ahead of anticipated timelines, reflecting the high unmet need for new treatments in bipolar disorder. The Phase 2/3 double-blind, placebo-controlled study enrolled approximately 256 patients. Patients were randomized to receive BHV-7000 75 mg once daily or placebo over a 3-week treatment period. The primary outcome measure of the study is the change from baseline to week 3 in mania symptom severity, as measured by the Young Mania Rating Scale (YMRS). Secondary objectives include response and remission rates, early onset of efficacy, depression symptom severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), and safety.
Irfan Qureshi MD, Chief Medical Officer of Biohaven, commented, "Biohaven continues to propel cutting edge science into reality in the clinic. Biohaven's proprietary MoDE degrader platform is a technology that has the potential to revolutionize precision treatment of a spectrum of common and rare autoimmune diseases. Targeted removal of IgG, b1AR autoantibodies and galactose deficient IgA1 has the potential to transform the treatment of rheumatoid arthritis, myasthenia gravis, autoimmune cardiomyopathy, IgAN, and many other immune mediated disorders. While advancing new compounds in immunology and inflammation, our R&D teams have also delivered important milestones for our ion channel and glutamate modulating agents. We are proud to have completed enrollment in the pivotal bipolar study with BHV-7000, months ahead of timelines and eagerly await topline results. And, our NDA submission for spinocerebellar ataxia represents the culmination of over 8 years of innovation, research, and commitment to patients with this devastating neurodegenerative disease. We believe troriluzole is a transformative breakthrough that offers new hope to individuals and families suffering from SCA who currently have no therapeutic options to alter the course of this relentless disease." Dr. Qureshi added, "We are extremely excited about the rapid progress across the portfolio and optimistic about the opportunities we have to make a positive impact on patients' lives and create value in 2025 and beyond."
About Biohaven
Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and nonclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit .
Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
MoDE is a trademark of Biohaven Therapeutics Ltd.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
[email protected]
+1 (201) 248-0741
Media Contact:
Mike Beyer
Sam Brown Inc.
[email protected]
+1 (312) 961-2502
SOURCE Biohaven Ltd.
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Clinical ResultPhase 1Fast TrackOrphan DrugBreakthrough Therapy
06 Dec 2024
Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated in ongoing Phase 2 and 3 clinical studies, demonstrating excellent tolerability at all doses evaluated without central nervous system (CNS) adverse effects typically associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood disturbances.
Qualitative assessment of online social media platforms and forums provided a unique perspective of the unmet needs that people with epilepsy are vocalizing outside of the clinical setting, including the negative impact that ASM associated adverse events have on their quality of life.
Additional nonclinical data presentations included characterization of BHV-7000 using optical electrophysiology as well as beneficial effects of BHV-7000 on pathogenic developmental epileptic encephalopathy-associated KCNQ2 variants
NEW HAVEN, Conn., Dec. 6, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) announced today that it is presenting expanded safety data from BHV-7000 multiple-dose studies at the American Epilepsy Society (AES) 2024 Annual Meeting, taking place December 6-10, 2024, in Los Angeles, California. Additional poster presentations highlight BHV-7000 nonclinical data and unmet needs that persist for people living with epilepsy, including the negative impact of adverse effects associated with current ASMs.
Jason Lerner, M.D., Medical Director and Epilepsy Clinical Lead at Biohaven, commented, "We are very excited to share the expanded safety results with the once-daily extended-release formulation being evaluated in ongoing Phase 2 and 3 clinical studies. We are encouraged to see BHV-7000 continue to demonstrate favorable safety and tolerability without dose-limiting toxicities or CNS adverse events commonly associated with other ASMs, such as somnolence. These results paired with previously demonstrated CNS target engagement in our Phase 1 EEG study and a nonclinical profile showing BHV-7000 is a selective Kv7.2/7.3 activator that dials out GABAA activation provide compelling rationale for why BHV-7000 offers a differentiated profile from other treatments currently available or in development."
Dr. Lerner continued, "The evidence to date with BHV-7000 represents a potential paradigm shift in the treatment of epilepsy as many patients continue to be burdened by adverse events and do not achieve adequate seizure control with existing medications. As we continue advancing 5 ongoing pivotal Phase 2/3 trials with BHV-7000, including studies in focal epilepsy and idiopathic generalized epilepsy, Biohaven remains committed to developing novel, efficacious, and well-tolerated therapies for people living with epilepsy."
In addition to 4 poster presentations at AES, Biohaven will be presenting 1 poster at the Partners Against Mortality (PAME) 2024 Conference in Los Angeles on Thursday, December 5th highlighting the patient-centric Phase 2/3 BHV-7000 study in idiopathic generalized epilepsy.
American Epilepsy Society 2024 Annual Meeting Presentation Highlights:
Poster 1.486: Phase 1 Multiple Ascending Dose Studies Demonstrate Safety and Tolerability of BHV-7000, a Novel Kv7 Potassium Channel Activator
BHV-7000 is a selective Kv7.2/7.3 activator that was safe and well-tolerated at dose levels up to 120 mg daily for 15 days with no dose-limiting toxicities; 120 mg exceeds the doses being evaluated in ongoing Phase 2 and 3 clinical studies of up to 75 mg daily in focal epilepsy, idiopathic generalized epilepsy, bipolar mania, and major depressive disorder.
There were low rates of CNS-related adverse events and no somnolence or cognitive/mood disturbances reported.
Most AEs were mild and resolved spontaneously; and there were no serious adverse events or severe adverse events.
New data with the BHV-7000 once-daily extended-release formulation demonstrated excellent tolerability.
Poster 1.512: A Qualitative Assessment of the Epilepsy Patient Experience Through Social Media and Web-based Forums
While seizure freedom remains the primary goal of epilepsy treatment, additional unmet needs of people living with epilepsy were assessed by investigating the patient experience directly through social media and online platforms where patients discuss epilepsy outside of a clinical setting.
Patient perspectives and unmet needs were identified across 3 areas: antiseizure medication-associated adverse events, mental health, and stigma.
The 4 most frequently discussed ASM associated adverse events included: sleepiness, insomnia, mood changes, and cognitive effects; comments from patients captured the negative impact these adverse events have on their quality of life.
People with epilepsy also reported a range of challenges with mental health, and the stigma associated with epilepsy pressured patients to remain silent about their struggles.
Poster 1.534: Pharmacological Characterization of BHV-7000, a Novel and Selective Activator of Kv7 Channels, Using All-optical Electrophysiology
The acute and chronic pharmacological effects of BHV-7000 on the excitability of primary rat cortical neurons were evaluated using the all-optical electrophysiology platform Optopatch (Quiver Biosciences), which measures neuronal activity with single-cell and single action potential resolution.
Concentration-dependent dampening of neuronal excitability was observed, consistent with previous data with BHV-7000 in other experimental paradigms.
Overall, BHV-7000 demonstrated potent in vitro effects to reduce neuronal activity impacting a diverse set of Optopatch functional features across the stimulus protocol, including spike timing and spike shape features in different stimulus periods, which indicates lower neuronal excitability near action potential threshold.
Poster 1.431: BHV-7000 Is a Potent M-current Activator with Efficacy on Multiple Epilepsy-associated KCNQ2 Variants
This in vitro study assessed the effects of BHV-7000 on 50 loss-of-function KCNQ2 variants.
BHV-7000 rescued current density in all tested pathogenic KCNQ2 variants.
Current density was restored to wild-type (WT) levels with BHV-7000 for most variants.
These findings support the potential therapeutic value of BHV-7000 in KCNQ2-related epilepsy associated with a wide range of pathogenic KCNQ2 variants.
Partners Against Mortality (PAME) 2024 Conference Highlights:
PAME Poster 41: A Modern Design for a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BHV-7000 in Idiopathic Generalized Epilepsy (IGE) With Generalized Tonic–Clonic Seizures (SHINE)
Epilepsy studies have traditionally been double-blind, placebo-controlled, change-from-baseline endpoint studies; in these studies, subjects receiving placebo for a fixed treatment duration remain at risk for continued seizures, injury, and Sudden Unexpected Death in Epilepsy (SUDEP).
SHINE (NCT06425159) is an innovative, ongoing registrational study in IGE with the selective Kv7 activator BHV-7000 with an efficient, patient-centric design utilizing an FDA-endorsed time to event endpoint that decreases time on placebo, potentially reducing the risk of exposure to additional seizures, injury, and SUDEP.
Full posters will be available on the
Posters and Presentations page at:
.
About BHV-7000
BHV-7000 is a novel and selective activator of Kv7.2/Kv7.3, a key ion channel involved in neuronal signaling and in regulating the hyperexcitable state, that is being developed for the treatment of epilepsy and mood disorders. BHV-7000 was rationally developed as a potent activator of heteromeric Kv7.2/7.3 potassium channels, the molecular substrate that underlies the M-current (IKM). BHV-7000 is highly differentiated from ezogabine (known as retigabine in Europe), a Kv7 activator that was previously approved for adjunctive treatment of partial-onset seizures in adults. In comparison with ezogabine, BHV-7000 belongs to a significantly different structural class and differentiates from ezogabine in key properties, including pharmacology, plasma stability and stability to photooxidation. In addition, BHV-7000 does not exhibit GABAA receptor positive allosteric molecular activity as seen with ezogabine and similar compounds, which may contribute to the poor tolerability of ezogabine. This lack of GABAA receptor activity may translate to improved tolerability by reducing the typical dose dependent side effect profile often seen in patients receiving ezogabine and other anti-seizure medications.
About Biohaven
Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and nonclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit
.
Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
[email protected]
+1 (201) 248-0741
Media Contact:
Mike Beyer
Sam Brown Inc.
[email protected]
+1 (312) 961-2502
SOURCE Biohaven Ltd.
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Clinical ResultPhase 1Drug ApprovalPhase 2
12 Nov 2024
Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million Achieved positive topline trial results from pivotal trial with troriluzole in spinocerebellar ataxia (SCA) Troriluzole 200 mg QD dosed orally in patients with SCA met the study's primary endpoint on the change from baseline on the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes Statistically significant superiority achieved on 9 consecutive, prespecified primary and secondary endpoints Both the study protocol and statistical analysis plan were submitted to, and reviewed by, the U.S. Food and Drug Administration (FDA) prior to topline data analysis Study designed in discussion with the FDA and utilized Phase 3 data and an external control of matched, untreated SCA subjects from the U.S. Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) in accordance with the FDA's Guidance on Real-World Evidence (RWE) of effectiveness CRC-SCA external control included contemporaneous natural history data gathered from 2010-2024 Planned New Drug Application (NDA) re-submission in 4Q 2024 Completed clarification meeting with CHMP Rapporteurs in 4Q 2024 and MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes Taldefgrobep alfa, a myostatin-inhibitor, Phase 3 topline data in spinal muscular atrophy (SMA) in 4Q 2024 and Phase 2 trial protocol in obesity expected in 4Q 2024 Advancing extracellular Molecular Degrader of Extracellular Protein (MoDE) programs 3 additional investigational agents expected to enter Phase 1 studies in the next quarter Anticipate Phase 1 update for BHV-1300, including subcutaneous formulation, before year-end Broad progress with TRPM3 antagonist Initiated pivotal Phase 2 trial evaluating BHV-2100, a TRPM3 antagonist, in the acute treatment of migraine Initiated separate proof of concept study with BHV-2100 in neuropathic pain Patient enrollment continues across 5 Phase 2/3 trials with Kv7 activator, BHV-7000, in epilepsy and mood disorders (bipolar and major depressive disorder (MDD)) with potential for multiple data readouts in 2025 Continued progress with antibody drug conjugate (ADC) portfolio BHV-1510 currently dosing cancer patients in Phase 1/2 study, advancing towards combination dosing of BHV-1510 with Libtayo® in 4Q 2024
Troriluzole 200 mg QD dosed orally in patients with SCA met the study's primary endpoint on the change from baseline on the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes Statistically significant superiority achieved on 9 consecutive, prespecified primary and secondary endpoints Both the study protocol and statistical analysis plan were submitted to, and reviewed by, the U.S. Food and Drug Administration (FDA) prior to topline data analysis Study designed in discussion with the FDA and utilized Phase 3 data and an external control of matched, untreated SCA subjects from the U.S. Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) in accordance with the FDA's Guidance on Real-World Evidence (RWE) of effectiveness CRC-SCA external control included contemporaneous natural history data gathered from 2010-2024 Planned New Drug Application (NDA) re-submission in 4Q 2024 Completed clarification meeting with CHMP Rapporteurs in 4Q 2024 and MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes
3 additional investigational agents expected to enter Phase 1 studies in the next quarter Anticipate Phase 1 update for BHV-1300, including subcutaneous formulation, before year-end
Initiated pivotal Phase 2 trial evaluating BHV-2100, a TRPM3 antagonist, in the acute treatment of migraine Initiated separate proof of concept study with BHV-2100 in neuropathic pain
BHV-1510 currently dosing cancer patients in Phase 1/2 study, advancing towards combination dosing of BHV-1510 with Libtayo® in 4Q 2024
NEW HAVEN, Conn. , Nov. 12, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ( Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the third quarter ended September 30, 2024 , and provided a review of recent accomplishments and anticipated upcoming developments.
Vlad Coric , M.D., Chairman and Chief Executive Officer of Biohaven , commented, "The team at Biohaven continues to advance multiple late and early stage assets that have the potential to change the current standard of care treatment paradigm across a number of diseases. Last quarter we announced positive topline results in our RWE trial assessing troriluzole for the treatment of spinocerebellar ataxia. Troriluzole (200 mg dosed orally) met the study's primary endpoint on the change from baseline in the f-SARA at 3 years in all study population genotypes, showed statistically significant superiority after both 1 and 2 years of treatment, and achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints. This was truly a watershed moment for the Company, given the implications of potentially bending the arc of one of the most intractable neurological diseases with no currently approved treatment options. SCA robs patients of their ability to speak, walk, and take care of themselves, and often shortens lifespans and has unfortunate intergenerational implications. We were encouraged by the robust dataset gathered to date and look forward to submitting an NDA to the FDA."
Dr. Coric continued, "We continue to execute across our broad pipeline including the recent initiation of our Phase 2 trial with BHV-2100 in acute migraine. Migraine burden and disability remain high despite advances in treatment; we believe our TRPM3 antagonistic approach has the potential to be a highly-effective, non-sedating, non-opioid treatment for pain and migraine. In the final months of 2024, we expect to report on a number of updates including SMA topline data and data across our MoDE™ platform including a SAD/MAD update and multiple INDs spanning β1AR for the potential treatment of dilated cardiomyopathy, galactose deficient IgA for IgA nephropathy and a further optimized IgG degrader for use in rare diseases."
Third Quarter 2024 and Recent Business Highlights
Achieved positive topline results in pivotal study of troriluzole in SCA - In September 2024 , the Company announced positive topline results from pivotal Study BHV4157-206-RWE demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after 3 years of treatment. The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2. Additionally, troriluzole achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints. SCA patients treated with troriluzole showed a 50-70% slowing of disease progression, representing 1.5-2.2 years delay in disease progression over the 3-year study period. The Company intends to submit an NDA to the FDA for troriluzole in the treatment of all SCA genotypes in 4Q 2024. The development program for troriluzole has been granted orphan and fast track designations, and is eligible for priority review. European Medicines Agency marketing authorization remains under review and Biohaven completed a clarification meeting with CHMP Rapporteurs in 4Q 2024. MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes. Initiated Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine - In September 2024 , the Company initiated a Phase 2 study of an orally administered TRPM3 antagonist, BHV-2100, in the acute treatment of migraine. The study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of two doses (75 mg and 150 mg) of BHV-2100 in the acute treatment of migraine. The trial is designed to support registration with FDA-accepted co-primary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours and is expected to enroll approximately 575 patients across 60 sites in the United States . Public offering - On October 2, 2024 , the Company closed its previously announced underwritten public offering of 6,052,631 of its common shares, which included the full exercise of the underwriters' option to purchase additional shares, at the public offering price of $47.50 per share. The net proceeds raised in the offering, after deducting underwriting discounts and estimated expenses of the offering payable by the Company, were approximately $269.9M . As of November 8, 2024 , we had 101,122,246 common shares outstanding.
Expected Upcoming Milestones:
We believe Biohaven is well positioned to achieve significant milestones in 2024 and 2025 across numerous programs:
Selective Kv7 Activator:
Continue 5 ongoing Phase 2/3 trials with BHV-7000 in focal epilepsy, idiopathic generalized epilepsy, MDD, and bipolar disorder
Troriluzole:
NDA submission to FDA on track for 4Q 2024, following release of pivotal topline results in SCA in September 2024 Two Phase 3 trials with troriluzole in OCD; expect to conduct interim analysis of the second Phase 3 OCD trial in 4Q 2024 and report topline data from first Phase 3 OCD trial in 1H 2025
Taldefgrobep alfa:
Report topline data from Phase 3 trial with taldefgrobep in SMA in 4Q 2024 Initiate Phase 2 trial with taldefgrobep in obesity in 4Q 2024 or early 2025
First-in-class TRPM3 Antagonist:
Continue advancing enrollment in Phase 2 trial with BHV-2100 in acute migraine and neuropathic pain (laser-evoked potential experimental pain paradigm)
TYK2/JAK1 Inhibitor:
Complete SAD/MAD studies with BHV-8000 and advance to Phase 2 in the coming months
MoDE™ Platform
Submit a total of 4 INDs in 2024 Continue to advance Phase 1 SAD and MAD studies with subcutaneous BHV-1300, with a further study update in 4Q 2024
Next Generation ADC Platform:
Advance Phase 1 Trop-2 directed program BHV-1510 in multiple tumor types
Capital Position:
Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million , which includes net proceeds of $269.9 million from the public offering of 6,052,631 common shares completed on October 2, 2024 .
Third Quarter 2024 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $157.6 million for the three months ended September 30, 2024 , compared to $95.5 million for the three months ended September 30, 2023 . The increase of $62.1 million was due to additional and advancing clinical trials, including late Phase 3 and Phase 2/3 studies, and preclinical research programs in 2024, as compared to the same period in the prior year. Non-cash share-based compensation expense was $7.2 million for the three months ended September 30, 2024 , an increase of $5.0 million as compared to the same period in 2023. Non-cash share-based compensation expense was higher in the third quarter of 2024, primarily due to our annual equity incentive awards granted in the fourth quarter of 2023 and the first quarter of 2024.
General and Administrative (G&A) Expenses: G&A expenses were $20.6 million for the three months ended September 30, 2024 , compared to $15.0 million for the three months ended September 30, 2023 . The increase of $5.5 million was partly due to increased non-cash share-based compensation expense, which was $5.0 million for the three months ended September 30, 2024 , an increase of $2.7 million as compared to the same period in 2023. Non-cash share-based compensation expense was higher in the third quarter of 2024 primarily due to our annual equity incentive awards granted in the fourth quarter of 2023 and the first quarter of 2024.
Other Income, Net: Other income, net was $17.8 million for the three months ended September 30, 2024 , compared to other income, net of $4.7 million for the three months ended September 30, 2023 . The increase of $13.1 million was primarily due to non-cash changes in the fair value of our derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), as well as increased investment income, partially offset by changes in the fair value of our forward contract liability recorded in connection with the Knopp Amendment.
Net Loss: Biohaven reported a net loss for the three months ended September 30, 2024 of $160.3 million , or $1.70 per share, compared to $102.6 million , or $1.50 per share, for the same period in 2023. Non-GAAP adjusted net loss for the three months ended September 30, 2024 was $164.1 million , or $1.74 per share, compared to $98.1 million , or $1.44 per share for the same period in 2023. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.
Non-GAAP Financial MeasuresThis press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods.
In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release.
About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer.
Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first in class therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission , including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
BIOHAVEN LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended September 30 ,
Nine Months Ended September30,
2024
2023
2024
2023
Operating expenses:
Research and development
$ 157,607
$ 95,517
$ 628,398
$ 238,468
General and administrative
20,561
15,030
66,782
43,872
Total operating expenses
178,168
110,547
695,180
282,340
Loss from operations
(178,168)
(110,547)
(695,180)
(282,340)
Other income, net
17,805
4,686
36,288
18,757
Loss before (benefit) provision for income taxes
(160,363)
(105,861)
(658,892)
(263,583)
(Benefit) provision for income taxes
(59)
(3,287)
687
(171)
Net loss
$ (160,304)
$ (102,574)
$ (659,579)
$ (263,412)
Net loss per share — basic and diluted
$ (1.70)
$ (1.50)
$ (7.50)
$ (3.86)
Weighted average common shares outstanding— basic and diluted
94,372,159
68,320,125
87,936,923
68,258,757
BIOHAVEN LTD.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share amounts)
September 30, 2024
December 31, 2023
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 84,390
$ 248,402
Marketable securities
294,426
133,417
Prepaid expenses
55,168
35,242
Income tax receivable
5,318
13,252
Other current assets
1,198
12,133
Total current assets
440,500
442,446
Property and equipment, net
18,276
17,191
Intangible assets
18,400
18,400
Goodwill
1,390
1,390
Other non-current assets
31,957
33,785
Total assets
$ 510,523
$ 513,212
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$ 19,744
$ 15,577
Accrued expenses and other current liabilities
63,520
39,846
Forward contract liability
69,030
—
Total current liabilities
152,294
55,423
Non-current operating lease liabilities
25,312
27,569
Derivative liability, non-current
12,320
—
Other non-current liabilities
4,591
2,245
Total liabilities
194,517
85,237
Shareholders' Equity:
Preferred shares, no par value; 10,000,000 shares authorized, no shares issuedand outstanding as of September 30, 2024 and December 31, 2023
—
—
Common shares, no par value; 200,000,000 shares authorized as of September30, 2024 and December 31, 2023 ; 94,899,193 and 81,115,723 shares issuedand outstanding as of September 30, 2024 and December 31, 2023 ,respectively
1,381,699
887,528
Additional paid-in capital
93,038
39,804
Accumulated deficit
(1,158,871)
(499,292)
Accumulated other comprehensive income (loss)
140
(65)
Total shareholders' equity
316,006
427,975
Total liabilities and shareholders' equity
$ 510,523
$ 513,212
BIOHAVEN LTD.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended September 30 ,
Nine Months Ended September30,
2024
2023
2024
2023
Reconciliation of GAAP to Non-GAAP adjusted net loss:
GAAP net loss
$ (160,304)
$ (102,574)
$ (659,579)
$ (263,412)
Add: non-cash share-based compensation expense
12,160
4,456
59,269
12,916
Add: (gain) loss from change in fair value of derivatives
(15,990)
—
(17,030)
—
Non-GAAP adjusted net loss
$ (164,134)
$ (98,118)
$ (617,340)
$ (250,496)
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:
GAAP net loss per share — basic and diluted
$ (1.70)
$ (1.50)
$ (7.50)
$ (3.86)
Add: non-cash share-based compensation expense
0.13
0.07
0.67
0.20
Add: (gain) loss from change in fair value of derivatives
(0.17)
—
(0.19)
—
Non-GAAP adjusted net loss per share — basic and diluted
$ (1.74)
$ (1.44)
$ (7.02)
$ (3.67)
MoDEs is a trademark of Biohaven Therapeutics Ltd. Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc.
Investor Contact:
Jennifer Porcelli Vice President, Investor Relationsjennifer.porcelli@biohavenpharma.com+1 (201) 248-0741
Media Contact:
Mike Beyer Sam Brown Inc. mikebeyer@sambrown.com+1 (312) 961-2502
View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-third-quarter-2024-financial-results-and-recent-business-developments-302303249.html
SOURCE Biohaven Ltd.
Phase 2Clinical ResultFast TrackFinancial StatementNDA
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Epilepsy, Idiopathic Generalized | Phase 3 | US | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | AU | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | AT | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | DE | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | IT | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | NL | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | PL | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | PT | 20 Jun 2024 | |
| Epilepsy, Idiopathic Generalized | Phase 3 | ES | 20 Jun 2024 | |
| Bipolar I disorder | Phase 3 | US | 28 May 2024 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | - | ejmnsdkbhf(shvlrbfrfn) = qkotwtzkeq znrjkzzbtl (wvgtooyqho ) View more | - | 09 Apr 2024 | |||
NEWS Manual  | Phase 1 | - | 11 | BHV-7000 | smpyekiwcy(plcsqqoksb) = the highest spectral power increases with BHV-7000 were seen in alpha, beta, and gamma frequency bands. eqodkgfkwy (ptmmouiutu ) View more | Positive | 01 Dec 2023 |
NEWS Manual | Phase 1 | - | 61 | BHV-7000 (4mg) | tbvvxdhdws(injyxayzqk) = jmkwoesval cjwgjlqeop (xxwjtuvzcm ) View more | Positive | 01 Dec 2023 |
BHV-7000 (10mg) | tbvvxdhdws(injyxayzqk) = vrikijfeal cjwgjlqeop (xxwjtuvzcm ) View more | ||||||
Not Applicable | - | ucqcjazkuw(hcscedazzo) = phyzzgyvax xlpyizyddl (krrqjjxylb ) | Positive | 04 Sep 2023 |
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