NEW HAVEN, Conn., Aug. 7, 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 diseases today
reported completion of enrollment in its pivotal Phase 3 preventive
treatment of migraine trial with rimegepant, its lead oral
calcitonin gene-related peptide (CGRP) receptor antagonist product
candidate.
Vlad Coric, M.D., CEO of Biohaven
commented, "Given rimegepant's high affinity for the CGRP receptor
and its relatively long half-life, we believe rimegepant may
possess unique "dual-therapy" action with a potential ability to
provide acute treatment of migraine attacks and preventive effects.
We are excited to complete enrollment in this Phase 3 preventive
trial. To our knowledge, rimegepant is currently the only small
molecule CGRP antagonist being developed for both the acute and
preventive indications in the treatment of migraine."
The Phase 3 trial of rimegepant in the preventive treatment of
migraine examines the efficacy and safety of rimegepant in adult
subjects who have suffered from migraine for at least one year and
who have a frequency of 4 to 14 migraine attacks of moderate to
severe intensity per month over the three months prior to
enrollment. The primary outcome measure is the change from baseline
at week 12 in the mean number of migraine days per month. Secondary
outcome measures include the achievement of at least a 50%
reduction from baseline in mean monthly migraine days across the
double-blind treatment phase, and the mean number of rescue
medication days per month, each as measured over the course of the
double-blind, treatment phase.
Robert Croop M.D., Chief
Development Officer – Neurology at Biohaven, commented, "Migraine
is the 6th most disabling illness in the world, where more
than 90% of sufferers are unable to work or function normally
during an attack. Our hope is to bring forward a new oral therapy
that is convenient for patients to administer, fulfills their needs
for acute and preventive therapies, and has the potential to give
back to these migraine sufferers significant portions of their
lives otherwise lost to disability caused by migraine."
Rimegepant has demonstrated efficacy and safety in four Phase
2/3 trials in the acute treatment of migraine and Biohaven
submitted New Drug Applications (NDAs) to the FDA for the Zydis ODT
and tablet formulations of rimegepant in 2Q2019. Biohaven is also
developing its product candidate BHV-3500, the first small molecule
CGRP receptor antagonist to be administered in an intranasal (IN)
formulation in human testing. Biohaven's pipeline now includes
product candidates across three novel mechanisms of action to
target central nervous system disorders: 1) CGRP receptor
antagonists for migraine and pain; 2) glutamate modulating agents
for the treatment of neurological and neuropsychiatric disorders,
and; 3) myeloperoxidase inhibition for neuroinflammatory disorders.
The Company expects to reach significant pipeline milestones in the
coming periods.
About Migraine
Approximately 40 million Americans
suffer from migraine. Acute attacks of migraine can differ in
intensity and frequency, with many being highly disabling. More
than 90 percent of migraine sufferers are unable to work or
function normally during an attack. In the Global Burden of Disease
Study, updated in 2015, migraine was ranked as the seventh highest
cause worldwide of years lost due to disability. CGRP receptor
antagonists represent a novel class of drug candidates for the
treatment of migraine and are the first new class specific to the
acute treatment of migraine in over 25 years. This unique and
specific mode of action potentially offers an alternative to
current agents, particularly for patients who have
contraindications to the use of triptans, such as those with
underlying cardiovascular diseases, or who either do not respond or
have inadequate or inconsistent response to triptans or are
intolerant to them.
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
refractory trigeminal neuralgia. The efficacy and safety profile of
rimegepant for the acute treatment of migraine, as compared to
placebo, 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 all 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/cgrp/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, Rutgers, and ALS Biopharma
LLC. Currently, Biohaven's lead development programs include
multiple compounds across its CGRP receptor antagonist, glutamate
modulation, and myeloperoxidase inhibitor platforms. Biohaven's
common shares are listed on the New York Stock Exchange and traded
under the ticker symbol BHVN. 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 effectiveness and safety
of rimegepant, 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 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 and the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, filed
with the Securities and Exchange Commission on May 8, 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.
Biohaven Contact
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.