• BHV-7000 differs pharmacologically and structurally from other known Kv7 compounds in development
  • BHV-7000 demonstrates potent anti-seizure activity without effects on neurobehavior in preclinical models
  • BHV-7000 CNS side effect profile in Phase 1 compares favorably to anti-seizure medications currently approved and in clinical development   

NEW HAVEN, Conn., March 14, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) announced today that it will present an oral and poster presentation demonstrating the preclinical efficacy and initial Phase 1 safety and tolerability of BHV-7000, a novel activator of heteromeric Kv7.2/7.3 potassium channels, on the 2023 American Society for Experimental Neurotherapeutics Annual Meeting (ASENT 2023) virtual platform, taking place March 13-15, 2023. The presentation and poster, titled "Discovery and characterization of BHV-7000: a novel KV7.2/7.3 activator for the treatment of epilepsy," can be viewed on the virtual meeting platform, accessible at www.asent.org/annual-meeting.  

(PRNewsfoto/BIOHAVEN LTD)

Steven Dworetzky, PhD, SVP of Kv7 Strategy and Development at Biohaven, who initially characterized the Kv7-encoding genes in the 1990s and is scientific founder of Biohaven's BHV-7000 program, said, "When epileptic patients experience seizures, their neurons undergo prolonged depolarization coupled with continuous action potential spikes unaccompanied by an intervening repolarization. The preclinical data we are presenting at ASENT today demonstrate that activating Kv7.2/7.3 with BHV-7000, a compound that is structurally and pharmacologically distinct from ezogabine, produced concentration-dependent hyperpolarization of the resting membrane potential, potentiated meaningful increases in action potential threshold, exhibited significantly lower GABAA activity than ezogabine, and delivered potent anti-seizure efficacy in the maximal electroshock seizure (MES) model, without negatively impacting neurobehavior."

Dr. Dworetzky continued, "Further, in the Phase 1 single ascending dose / multiple ascending dose (SAD/MAD) clinical trial, BHV-7000 was well-tolerated at single doses up to 100 mg and multiple doses up to 40 mg per day for 15 days. Most adverse events were mild and resolved spontaneously, and there were no serious or severe adverse events or dose-limiting toxicities reported. Importantly, in BHV-7000 treated subjects in the MAD study, CNS-related adverse events typically associated with other anti-seizure medications were not reported."

Michael Bozik, M.D., President, Ion Channel Research & Development of Biohaven, added, "The Phase 1 safety and tolerability data paired with the preponderance of preclinical efficacy data we have generated to date provide confidence that the doses we are evaluating for BHV-7000 have the potential to deliver efficacy without the debilitating CNS-related adverse effects associated with other anti-seizure medications, e.g. dizziness, somnolence, diplopia – a profile that would be revolutionary for epilepsy patients."

The presentation slides and an accompanying posters will be available on the Events and Presentations page of the Investors section of Biohaven's website at www.biohavenpharma.com.

About Biohaven
Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's experienced management team brings with it a track record of delivering new drug approvals for products for diseases such as migraine, depression, bipolar and schizophrenia. The company is advancing a pipeline of therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability, glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia and myostatin inhibition for neuromuscular diseases. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain, CD-38 antibody recruiting, bispecific molecules for multiple myeloma, antibody drug conjugates (ADCs), and extracellular target degrader platform technology (MoDE™) with potential application in neurological disorders, cancer, and autoimmune diseases. More information about Biohaven is available at www.biohaven.com.

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 Food and Drug Administration; 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; 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 new 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 Contacts:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

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SOURCE BIOHAVEN LTD

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