NEW HAVEN, Conn., July 24, 2017 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today
that it has commenced enrollment in the first of its two
registrational Phase 3 clinical trials to evaluate the safety and
efficacy of orally-dosed rimegepant (BHV-3000) for the acute
treatment of migraine. Biohaven expects to begin enrollment in
the second Phase 3 clinical trial this summer and report topline
results for both studies in the first half of 2018.
"Large numbers of migraine patients, including those with
cardiovascular disease or hypertension for whom existing treatment
options such as triptans are contraindicated, may benefit from a
safe and effective oral CGRP receptor antagonist medication that
provides rapid and sustained relief from pain," said Vlad Coric, M.D., Chief Executive Officer at
Biohaven. "Based on the results of its Phase 2b clinical
trial, we believe rimegepant has the potential to be a
best-in-class treatment option, combining early, comprehensive, and
durable efficacy with convenient oral dosing, so that patients are
spared the need for any intravenous or subcutaneous
administration."
Biohaven plans to conduct two double-blinded, placebo-controlled
Phase 3 clinical trials to evaluate the efficacy and safety of 75
mg of rimegepant, Biohaven's innovative, orally-dosed small
molecule CGRP receptor antagonist, for the acute treatment of
migraine. The co-primary endpoints of the studies are freedom from
pain at two hours post-dosing and a demonstrated effect on the
patient's most bothersome symptom (nausea, photophobia or
phonophobia) at two hours post-dosing. Patients in the Phase 3
clinical trials will be eligible to participate in a long-term
safety study.
In a previously completed Phase 2b clinical trial, the 75 mg
dose of rimegepant was observed to have achieved statistically
significant improvement compared to placebo at two hours
post-dosing on all four key migraine symptoms: pain, nausea,
photophobia and phonophobia. To the company's knowledge, rimegepant
is the only oral, small molecule CGRP receptor antagonist currently
in development that has achieved statistically significant
improvement on all four of these key migraine symptoms within a
single study. Rimegepant treated patients also experienced durable
efficacy, achieving statistically higher rates of pain freedom at
24 and 48 hours post-dosing compared to placebo.
Rimegepant is the most advanced candidate in Biohaven's CGRP
receptor antagonist platform. Biohaven is also pursuing the
development of BHV-3500 for the treatment of patients with chronic
and episodic migraine. Biohaven's CGRP platform is focused on
delivering oral or intranasal therapies for migraine that are easy
to use for patients when and where a debilitating migraine attack
hits.
"We are very pleased to begin the Phase 3 development of this
important product candidate for migraine sufferers. We also plan to
demonstrate, through our long-term safety study, a low risk of
cardiovascular side effects and favorable safety profile in
addition to comprehensive and durable treatment effects observed in
the acute studies," said Elyse
Stock, M.D., Chief of Portfolio Development and Strategy at
Biohaven.
About Migraine
Migraine is both widespread and
disabling neurological disorder. The Migraine Research Foundation
ranks migraine as the world's third most prevalent illness,
affecting approximately 36 million people in the United States. Current treatment
approaches, such as triptans, can be limited by headache recurrence
within 24 hours after taking migraine medication, as well as
cardiovascular contraindications and warnings.
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, ALS Biopharma LLC
and Massachusetts General Hospital. Currently, Biohaven's lead
development programs include multiple compounds across its CGRP
receptor antagonist and glutamate modulation platforms. The
company'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,
including the Company's timing of the expected data readouts from
the Company's registrational trials of rimegepant, the potential
results of the trials and the Company's planned long-term safety
study of rimegepant and its potential to be a best-in-class
treatment option for the acute treatment of migraine, as well as
the size of the potential market for rimegepant, are
forward-looking statements. The use of certain words, including the
"believe" and "will" and similar expressions are intended to
identify forward-looking statements. The Company may not actually
achieve the plans and objectives disclosed in the forward-looking
statements and you should not place undue reliance on the Company's
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,
including uncertainties relating to the future clinical success of
rimegepant, and whether the results observed in the Phase 2b
clinical trial will be observed in the Phase 3 pivotal trials.
Additional important factors to be considered in connection with
forward-looking statements are described in the "Risk Factors"
section of the Company's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on June 16, 2017. 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, the Chief Executive Officer
at Vlad.Coric@biohavenpharma.com.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.