- 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) (PRNewsfoto/BIOHAVEN LTD)](https://mma.prnewswire.com/media/1912969/Biohaven_Full_Color_rgb_2022SEPT03_Logo.jpg)
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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