NEW HAVEN, Conn., July 1, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological and
neuropsychiatric diseases, today announced that the first patient
has been enrolled in a Phase 2 clinical trial assessing the
efficacy and safety of rimegepant in treatment refractory
trigeminal neuralgia.
Trigeminal neuralgia is a neuropathic pain disorder
characterized by recurrent, paroxysmal, lancinating pain in the
distribution of one or more branches of the trigeminal nerve.
These episodic bouts of severe facial pain can last seconds to
minutes, occur several times per day, and often result in
significant disability. The neuropeptide calcitonin gene-related
peptide (CGRP) is thought to play an important role in the
development of neuronal sensitization and neuropathic pain and its
aberrant release from the trigeminal nerve has been implicated in
the pathophysiology of trigeminal neuralgia. Rimegepant is
Biohaven's lead oral, selective and potent small molecule
calcitonin gene-related peptide (CGRP) receptor antagonist
currently being developed for the treatment of migraine.
Robert Croop, M.D., Biohaven
Chief Development Officer - Neurology , commented, "CGRP is an
important mechanistic target that has been implicated in a variety
of diseases. Emerging evidence suggests that aberrant release
of CGRP from the trigeminal ganglion plays a critical role in the
development of pain syndromes such as trigeminal neuralgia. We
believe this study is the oral first CGRP receptor antagonist
being studied for use as a potential treatment of trigeminal
neuralgia and extends our CGRP clinical research beyond
migraine."
This trial will enroll patients in a double-blind,
placebo-controlled, crossover design at Johns Hopkins Medical
Center. Researchers will evaluate the efficacy and safety of
rimegepant in treating trigeminal neuralgia in patients who failed
to respond adequately to pharmacotherapy. The primary outcome
measure is the change in a patient's average Numeric Pain Rating
Scale between the two treatment phases of the study.
Additional details about the trial [NCT03941834] can be found
at www.clinicaltrials.gov.
Melissa Wolfe Beiner, M.D.,
Director of Research and Development and Medical Lead for the
Trigeminal Neuralgia development program at Biohaven commented,
"Biohaven has worked closely with leading experts in the field from
Johns Hopkins Medical Center, Dr. Tina
Doshi and Dr. Michael Lim, to
advance this Phase 2 clinical trial in patients with treatment
refractory trigeminal neuralgia." Dr. Wolfe Beiner added, "
While trigeminal neuralgia is a rare disease, the patient burden
associated with this disorder is significant. We are excited
about exploring the efficacy of rimegepant, our small molecule CGRP
receptor antagonist, in the treatment of Trigeminal Neuralgia."
About Rimegepant
Rimegepant is Biohaven's orally-dosed calcitonin
gene-related peptide (CGRP) receptor antagonist, which the Company
is developing as a treatment for migraine and trigeminal neuralgia.
The efficacy and safety profile of rimegepant for the acute
treatment of migraine has now been established across four
randomized controlled trials to date: three completed pivotal Phase
3 trials, and a Phase 2b trial.
The co-primary endpoints achieved in the three Phase 3 trials are
consistent with regulatory guidance from the FDA and provided the
basis for Biohaven's NDA submission to the FDA in the second
quarter of 2019. More information about rimegepant can be
found at the Company's
website: https://www.biohavenpharma.com/science-pipeline/rimegepant
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a
portfolio of innovative, late-stage product candidates targeting
neurological diseases, including rare disorders. Biohaven has
combined internal development and research with intellectual
property licensed from companies and institutions including
Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and
Massachusetts General Hospital. Currently, Biohaven's lead
development programs include multiple compounds across its CGRP
receptor antagonist, glutamate modulation and myeloperoxidase
inhibition platforms. More information about Biohaven is available
at www.biohavenpharma.com.
Forward-Looking Statements
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of the Company's management. All
statements, other than statements of historical facts, included in
this press release regarding the Company's business and product
candidate plans and objectives are forward-looking statements.
Forward-looking statements include those related to: the expected
timing, commencement and outcomes of the Company's planned and
ongoing clinical trials, the timing of planned interactions and
filings with the FDA, the timing and outcome of expected regulatory
filings, the expected issuance of preferred stock to Royalty
Pharma, the potential commercialization of the Company's product
candidates and the potential for the Company's product candidates
to be first in class or best in class therapies. The use of certain
words, including "believe", "continue", "may", "on track",
"expects" and "will" and similar expressions, are intended to
identify forward-looking statements. Various important factors
could cause actual results or events to differ materially from
those that may be expressed or implied by our forward-looking
statements. Additional important factors to be considered in
connection with forward-looking statements are described in the
"Risk Factors" section of the Company's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on February 28, 2019. The forward-looking statements
are made as of this date and the Company 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.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.