- Biohaven initiated a pivotal Phase 2 trial evaluating
BHV-2100 in the acute treatment of migraine
- BHV-2100 is a potential first-in-class, potent,
orally administered Transient Receptor Potential Melastatin-3
(TRPM3) antagonist— a novel, highly selective, and non-opioid
investigational treatment being developed for migraine and other
pain disorders
- Despite recent treatment advances, migraine remains a
leading cause of disability and burden, impacting 40 million people
in the US and 1 billion world-wide
NEW
HAVEN, Conn., Sept. 30,
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, announced today that it has initiated a pivotal Phase 2
study of the potential first-in-class, orally administered TRPM3
antagonist, BHV-2100, in the acute treatment of migraine.
Richard B. Lipton, M.D., the
Edwin S. Lowe Professor and Vice Chair of Neurology at the Albert
Einstein College of Medicine, and Director of the Montefiore
Headache Center commented, "The burden of migraine remains high,
and many patients experience inadequate relief or suffer from
tolerability issues from existing therapies. There remains a need
for novel treatments for migraine to lessen disease burden and
disability. The TRPM3 ion channel has been implicated in the
pathophysiology of migraine, and this trial is the first to assess
efficacy and tolerability of a novel agent targeting this mechanism
in migraine."
The pivotal Phase 2 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 coprimary endpoints of pain freedom and freedom from
most bothersome symptom at 2 hours. The trial will enroll
approximately 575 patients across 60 sites in the United States. Additional information can
be found at www.clinicaltrials.gov/study/NCT06603623.
Beth Emerson, M.D., M.B.A.,
Executive Medical Director and Development Lead for Migraine at
Biohaven, stated "Biohaven remains extremely committed to advancing
novel therapeutic options for people suffering from migraine.
Building on our deep passion, unparalleled expertise, and
successful track record of developing innovative medications that
are currently making a difference for migraine patients today, our
team is thrilled to embark on this important program to potentially
deliver a new, cutting-edge therapy for migraine. This includes a
large number of patients who do not respond to existing therapies,
estimated to be approximately one-third of the 40 million patients
in the US who desperately need more treatment options."
BHV-2100 is a potentially first-in-class, potent, selective,
orally administered TRPM3 antagonist— a novel, non-sedating
non-opioid treatment for migraine and pain. BHV-2100 demonstrated
excellent safety and tolerability across all doses tested in Phase
1 trials in healthy adults, without the thermoregulatory adverse
events observed with other TRP antagonists or sedation associated
with other pain medications. Additionally, the pharmacokinetic
profile is very well-suited for use in the treatment of acute
migraine. Single doses of BHV-2100 demonstrated rapid absorption
and sustained concentrations above predicted efficacious levels at
all doses tested after 20 minutes with maximal drug concentrations
achieved at approximately 1.5 to 2 hours and a half-life of
approximately 8-12 hours.
Beth Morris, Vice President of
Biohaven Clinical Operations, added "Biohaven has deep expertise in
running clinical trials in migraine and this study will assess an
important new potential therapy for patients. I am proud of our
clinical operations team for efficiently advancing this trial into
Phase 2 after completing the initial Phase 1 trial earlier this
year. Days matter for patients and if this study is positive, we
will be one step closer to delivering another novel treatment
option to better meet the needs of people with migraine: to resolve
symptoms and to return to their lives quickly."
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 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 (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 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 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.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
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SOURCE Biohaven Ltd.
