LOS ANGELES, April 22, 2018 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced
the results of key secondary outcome measures from Phase 3 clinical
trials (BHV3000-301 and BHV3000-302) of rimegepant, the first oral
CGRP receptor antagonist to deliver positive data on pain freedom
and most bothersome symptom in two pivotal Phase 3 trials in acute
treatment of migraine. As previously reported, rimegepant met the
co-primary efficacy endpoints with significant superiority to
placebo, at two hours post-dose, on pain freedom and freedom from
the most bothersome symptom (MBS); endpoints which, according to
FDA guidance, are needed for registrational filing. These clinical
trials showed an early separation from placebo and a profile of
continued improvement after a single dose of rimegepant in patients
who did not take any rescue medications.
A durable effect with rimegepant was achieved with pain freedom
lasting up to 48 hours following a single dose. The percent of
patients experiencing pain freedom between 0 to 8 hours after
dosing is depicted in the Kaplan-Meier curves in Figure 1. The
percent of patients experiencing sustained pain freedom from 2 to
24 hours and through 2 to 48 hours is shown in the accompanying
table. Increasing benefit is evident from 2 to 4 hours with
durability of these effects lasting through 48 hours.
Figure 1: Durable Treatment Effects on Pain
Freedom1
Approximately 90% of patients who took rimegepant and no rescue
medications achieved the clinically important endpoint of pain
relief within 8 hours, which signifies an important return to daily
function (Figure 2). Onset of pain relief was observed early with
numerical separation evident approximately 30-45 minutes
post-dosing. By 90 minutes statistical significance was achieved in
both studies. Pain relief was sustained throughout 48 hours (Figure
2). The sustained pain relief profile was similar to that observed
for sustained pain freedom.
Figure 2: Durable Treatment Effects on Pain
Relief2
Pain relief is associated with reduced disability and function
as shown in these studies (Figure 3). Rimegepant-treated patients
showed improvement on functional disability at 2 hours post-dosing
in both pivotal trals. This outcome is clinically important because
it indicates the patient's recovery and ability to resume daily
activities.
Figure 3: Freedom from Functional Disability
(Patients Achieving Normal Function)3
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, commented, "We are proud to be the first to
deliver a positive dataset from two Phase 3 pivotal trials meeting
current FDA guidance that shows robust and durable clinical benefit
from a single dose of an oral CGRP receptor antagonist in the acute
treatment of migraine. The strength of these data are highlighted
by rimegepant showing benefits over placebo in 11 out of 13
prespecified primary and secondary outcome measures in both trials.
Our observations in both trials of comprehensive and durable
efficacy, a favorable safety and tolerability profile, and the ease
of oral dosing, together represent an attractive profile to submit
to regulatory authorities with the goal of ultimately bringing
relief to patients suffering from migraine."
Richard B. Lipton, M.D., Vice
Chair of Neurology, Professor of Epidemiology and Population Health
and Director of the Montefiore Headache Center, at the Albert
Einstein College of Medicine, and Chair of Biohaven's CGRP
Scientific Advisory Board added, "The single dose data from these
two clinical trials are very exciting as rimegepant brings forward
a novel mechanism of action that has demonstrated important
clinical benefit to patients. Most of the patients I see with
migraine are actively working and raising children, and relieving
pain and restoring function means they can once again take care of
their families and return to work. The new data reviewed today
encourages me that rimegepant, if approved, can meet their needs
for an acute treatment with lasting clinical benefit."
Over 36 million Americans suffer from migraine. Acute attacks of
migraine can differ in intensity and frequency, with many being
highly disabling. More than 90% of migraine sufferers are unable to
work or function normally during an attack. 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 those who have contraindications
to the use of triptans, such as patients with underlying
cardiovascular diseases, or for patients who do not respond to
triptans.
For full presentation including use of rescue medications,
patient preference, safety summary and other secondary outcome
measures see the Events page on the company website (see link
below).
Conference Call and Webcast
Biohaven hosted a conference call and webcast on April 22, 2018 concurrent with the American
Academy of Neurology meeting in Los
Angeles to discuss the secondary outcome measures available
from these two Phase 3 clinical trials. To access the audio webcast
with slides, please visit the "Events" page in the Investors
section of the Company's website at
http://investors.biohavenpharma.com/events. An archive of today's
teleconference and webcast will be available for 6 months following
the call.
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
NDA submission for rimegepant and its potential to be an improved
treatment option for the acute treatment of migraine, are
forward-looking statements. The use of certain words, including
"believe" and "will" and similar expressions, is 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 that topline data is based on preliminary
analysis of key efficacy and safety data, and such data could
change following a more comprehensive review and evaluation of more
extensive data from the trials that the Company has not yet
received, and these preliminary conclusions may not accurately
reflect the complete results of the clinical trials, and
uncertainties relating to the timing for submitting an NDA and the
potential regulatory approval of rimegepant. 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 March 6, 2018
and other filings Biohaven makes with the U.S. Securities and
Exchange Commission from time to time. 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.