NEW HAVEN, Conn., Nov. 16, 2017 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that it
is completing enrollment today in the first of its two
registrational Phase 3 clinical trials, Study BHV3000-301, to
establish the safety and efficacy of orally-dosed rimegepant.
Study BHV3000-301 has enrolled over 1,400 subjects since July
2017. Rimegepant is a second generation, oral, calcitonin
gene related peptide (CGRP) receptor antagonist being developed for
the acute treatment of migraine. Rimegepant has composition of
matter protection until 2030, not including patent term adjustment
or any potential patent term extension. Rimegepant is one of only
two small molecule CGRP-receptor antagonists in late stage clinical
development.
CGRP-receptor antagonists represent a novel class of drug
candidates designed to block the molecules in the body responsible
for pain and associated symptoms that occur during a migraine
attack. Additionally, large numbers of migraine patients,
especially those with cardiovascular disease or hypertension for
whom existing treatment options such as triptans are
contraindicated, may benefit from safe and effective oral
CGRP-receptor antagonists since this class of drugs is not
associated with vasoconstriction.
Vlad Coric, M.D., Chief Executive
Officer at Biohaven, commented, "Completing enrollment in this
large Phase 3 pivotal trial in four months reflects the high unmet
need of people with migraine and dissatisfaction with current
treatment approaches. Our team has focused on advancing small
molecule CGRP-receptor antagonists in convenient and easy to use
oral or intranasal formulations for patients to control migraines
when and where a debilitating attack hits. We want to give
patients the means to control their migraines in their own
hands—tablets comprise the vast majority of migraine therapy
prescriptions reflecting patient preference while nasal
formulations provide rapid, non-invasive treatment. Based upon our
Phase 2 data, we believe our lead candidate, rimegepant, has the
potential to be a best-in-class and first-in-class treatment option
for the acute treatment of migraine."
In a previously completed Phase 2b clinical trial, the 75 mg
dose of rimegepant was observed to have achieved a 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
improvements 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. Durability of
treatment response is an important unmet need not fulfilled by
current treatment options.
"We are very pleased to accomplish this important step in the
development of rimegepant and continue our work to bring this
important product candidate forward for migraine sufferers. The
rimegepant development program is designed to demonstrate
comprehensive and durable treatment benefits and a favorable safety
profile. Rimegepant may provide a new approach to treating migraine
without the cardiovascular risks associated with other drugs," said
Robert Croop, M.D., Chief
Development Officer – Neurology, at Biohaven.
Biohaven is conducting two double-blind, 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 freedom from the patient's most
bothersome symptom (nausea, photophobia or phonophobia) at two
hours post-dosing. Patients who have participated in the Phase 3
clinical trials may be eligible to participate in a long-term
safety study. In addition to rimegepant, Biohaven is also pursuing
the development of its third generation CGRP-receptor antagonist,
BHV-3500, for the acute and preventive treatment of migraine.
About Migraine
Migraine is both a widespread and disabling neurological
disease. 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 November 14, 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.