Biohaven's first-in-class Molecular Degrader of Extracellular Proteins (MoDE™) technology targeting IgG removal, BHV-1300, was selected for an oral presentation at AAN highlighting its novel mechanism of action and the latest preclinical data demonstrating rapid, robust, and selective target removal Biohaven announces it will present safety and IgG lowering data from its ongoing single ascending dose (SAD) study of BHV-1300 at the company's annual R&D day at the Yale Innovation Summit in New Haven, Connecticut on May 29, 2024 Safety, tolerability, and target engagement data showing the differentiated profile of BHV-7000 as a potential best-in-class Kv7 activator will be presented as both oral and poster presentations; the Phase 2/3 focal epilepsy program is now enrolling patients AAN Abstract of Distinction awarded to BHV-2100, which demonstrated potent reversal of pain in preclinical models and favorable initial safety and pharmacokinetic data in Phase 1 studies, highlighting the potential for TRPM3 antagonism as a novel nonopioid target to treat pain and migraine Biohaven announces the Data Monitoring Committee for its Phase 3 trial in obsessive-compulsive disorder convened in the second quarter to review the interim analysis and informed the Company that the study may continue Other presentations and posters include development of the PARCOMS, a new outcome measure for Parkinson's disease clinical trials, application of machine learning in video assessment of gait, and data demonstrating a reduced risk for Parkinson's disease in patients taking anti-inflammatory agents Three oral presentations and 6 poster presentations from the Biohaven Clinical and Health Outcomes group describe the development and validation of novel scales and natural history studies in support of troriluzole and BHV-8000 development programs, the impact of immune-modulating therapy in Parkinson's disease, the burden of illness in focal epilepsy and KCNQ2-DEE (BHV-7000), and the application of AI machine learning technology to quantify patient mobility with troriluzole in spinocerebellar ataxia DENVER, CO and NEW HAVEN, Conn., April 13, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) announced today that 20 abstracts, including 8 oral presentations and 12 posters, will be featured this weekend starting April 13th at the 2024 American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, Colorado. The presentations highlight Biohaven's leadership in neuroscience and extensive development programs evaluating novel therapies to treat neurological diseases, with abstracts covering programs that include Kv7 ion channel modulation, molecular degraders of extracellular protein (MoDEs), TRPM3 antagonism, TYK2/JAK1 inhibition, glutamate modulation, and myostatin inhibition. Irfan Qureshi, M.D., Chief Medical Officer of Biohaven, commented, "The research being presented at the AAN Annual Meeting emphasizes Biohaven's commitment to developing new therapeutic options across a range of neurological diseases. By targeting novel mechanisms of action, differentiated from currently available treatments and other therapies in development, and following innovative science, Biohaven continues to strive for better treatments for people living with neurological disorders. We are particularly honored that the AAN Science Committee selected our BHV-2100 (TRPM3) abstract as an AAN Abstract of Distinction, recognizing it as the top abstract in the pain category. Following the completion of Phase 1 studies in the first half of 2024, we look forward to initiating a Phase 2 study with BHV-2100 in migraine in the second half of the year and are excited by the potential for this novel nonopioid approach to treat pain." Vlad Coric M.D., Chief Executive Officer and Chairman of Biohaven, added, "Our leadership in neuroscience research is on full display at the AAN Annual Meeting with the breadth and depth of clinical, epidemiological, and preclinical programs highlighted in our scientific presentations. Central nervous system (CNS) disorders continue to represent one of the highest unmet medical needs facing our society and we must act urgently to bring better treatments to patients and improve clinical outcomes. We believe that the next generation of therapies for CNS disorders will include MoDEs for autoimmune disorders, ion channel modulation for epilepsy, migraine and other pain disorders, immune modulation for neurodegenerative disorders including Parkinson's and Alzheimer's diseases, myostatin targeting drugs for neuromuscular disorders and glutamate modulating agents for neuropsychiatric disorders. I am so proud of the team at Biohaven who are working tirelessly to alleviate the burden of these devastating disorders." The complete list of Biohaven's accepted abstract titles is below. Full abstracts can be viewed online at https://index.mirasmart.com/AAN2024/. Novel Bispecific Degrader BHV-1300 Achieves Rapid, Robust, and Selective IgG Reduction in Preclinical Models Including Nonhuman Primates BHV-2100, a First-in-class TRPM3 Antagonist for the Treatment of Pain (AAN Abstract of Distinction) Characterization of BHV-7000: A Novel Kv7.2/7.3 Activator for the Treatment of Seizures Re-weighting MDS-UPDRS Motor Items for Optimal Sensitivity to Parkinson's Disease Progression in Untreated Patients Using Parkinson's Progression Markers Initiative Data Population Pharmacokinetic Modeling of Riluzole After Administration of a Next Generation Prodrug Troriluzole Next Generation Prodrug Troriluzole: Increased Bioavailability of Riluzole with No Food Effect in Healthy Subjects Phase 1 Study Evaluating the Safety and Tolerability of BHV-7000, a Novel, Selective Kv7.2/7.3 Potassium Channel Activator, in Healthy Adults Novel, Selective Kv7.2/7.3 Potassium Channel Activator, BHV-7000, Demonstrates Dose-dependent Pharmacodynamic Effects on EEG Parameters in Healthy Adults Determinants of Health-related Quality of Life of Patients with Focal Epilepsy: A Systematic Literature Review Functional Impairments in Patients with KCNQ2-DEE: Associations Among Key Clinical Features
Re-weighting MDS-UPDRS Part II Items for Optimal Sensitivity to Parkinson's Disease Progression Using Parkinson's Progression Markers Initiative Natural History Data Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Doses of a Next Generation Prodrug Troriluzole in Healthy Subjects Troriluzole Exhibits Favorable Hepatic Safety Profile Across a Diverse Range of Disorders No Clinically Relevant Effects of Hepatic Impairment on the Pharmacokinetics of a Next Generation Prodrug Troriluzole Psychometric Validation of the Modified-functional Scale for the Assessment and Rating of Ataxia Posters and presentations will be available on the
Posters and Presentations page after the conference at
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; 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. Vice President, Investor Relations
Biohaven AAN 2024 Oral & Poster Presentations:
Functional Impairments in Patients with KCNQ2-DEE: Associations Among Key Clinical Features
Sunday 4/14/24: 8:00-9:00
Colorado Convention Center – Exhibit Hall B-E
Sunday 4/14/24: 11:45 - 12:45
Colorado Convention Center - Exhibit Hall
Sunday 4/14/24: 1:00-3:00 (1:24-1:36)
Colorado Convention Center- Mile High 4CD
Re-weighting MDS-UPDRS Motor Items for Optimal Sensitivity to Parkinson's Disease Progression in Untreated Patients Using Parkinson's Progression Markers Initiative Data Sunday 4/14/24: 1:00-3:00 (1:36-1:48)
Colorado Convention Center- Mile High 4CD
Population Pharmacokinetic Modeling of Riluzole After Administration of a Next Generation Prodrug Troriluzole Sunday 4/14/24: 1:00 - 3:00 (2:12-2:24)
Colorado Convention Center - Four Seasons 2/3
Next Generation Prodrug Troriluzole: Increased Bioavailability of Riluzole with No Food Effect in Healthy Subjects Sunday 4/14/24: 3:30 - 5:30 (4:30-4:42)
S5 - ALS and CMT: New Therapeutic Approaches Colorado Convention Center - Four Seasons 1
BHV-2100, A First-In-Class TRPM3 Antagonist for the Treatment of Pain Monday 4/15/24: 11:15-12:15 (11:27-11:39)
Colorado Convention Center 605
Troriluzole Exhibits Favorable Hepatic Safety Profile Across a Diverse Range of Disorders Monday 4/15/24: 11:45 - 12:45
Colorado Convention Center - Exhibit Hall
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Doses of a Next Generation Prodrug Troriluzole in Healthy Subjects Monday 4/15/24: 11:45 - 12:45
Colorado Convention Center - Exhibit Hall
No Clinically Relevant Effects of Hepatic Impairment on the Pharmacokinetics of a Next Generation Prodrug Troriluzole Monday 4/15/24: 11:45 - 12:45
Colorado Convention Center - Exhibit Hall
Tuesday 4/16/24: 8:00-9:00
Colorado Convention Center – Exhibit Hall
Psychometric Validation of the Modified-functional Scale for the Assessment and Rating of Ataxias Tuesday 4/16/24: 11:45-12:45
Colorado Convention Center – Exhibit Hall
Tuesday 4/16/24: 11:45-12:45
Colorado Convention Center – Exhibit Hall
Phase 1 Study Evaluating the Safety and Tolerability of BHV-7000, a Novel, Selective Kv7.2/7.3 Potassium Channel Activator, in Healthy Adults Tuesday 4/16/24: 5:30 - 6:30
Colorado Convention Center - Exhibit Hall
Novel, Selective Kv7.2/7.3 Potassium Channel Activator, BHV-7000, Demonstrates Dose-dependent Pharmacodynamic Effects on EEG Parameters in Healthy Adults Tuesday 4/16/24: 5:30 - 6:30
Colorado Convention Center - Exhibit Hall
Determinants of Health-related Quality of Life of Patients with Focal Epilepsy: A Systematic Literature Review Wednesday 4/17/24: 8:00-9:00
Colorado Convention Center – Exhibit Hall
Characterization of BHV-7000: A Novel Kv7/2/7.3 Activator for the Treatment of Seizures Wednesday 4/17/24: 1:00-3:00 (2:00-2:12)
S29- Epilepsy Diagnostics and Therapeutics Colorado Convention Center 605
Wednesday 4/17/24: 3:30-5:30 (5:06-5:18)
Colorado Convention Center – Four Seasons 4
Re-weighting MDS-UPDRS Part II Items for Optimal Sensitivity to Parkinson's Disease Progression Using Parkinson's Progression Markers Initiative Natural History Data Wednesday 4/17/24: 5:30-6:30
Colorado Convention Center – Exhibit Hall
Novel Bispecific Degrader BHV-1300 Achieves Rapid, Robust, and Selective IgG Reduction in Preclinical Models Including Nonhuman Primates Thursday 4/18/24: 1:00 - 3:00 (1:36-1:48)
S43 - General Neurology 2
Colorado Convention Center - 108/110/112