NEW HAVEN, Conn., May 7, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced
additional safety and preliminary efficacy results from its ongoing
long-term, open-label safety study of its oral calcitonin
gene-related peptide (CGRP) receptor antagonist, rimegepant. Based
upon this interim analysis of Study BHV3000-201 (NCT03266588 or
"Study 201"), database cutoff of February
20, 2019, rimegepant was well tolerated with long-term
dosing up to one year in patients with migraine. Thus far, 105,192
doses of rimegepant 75 mg was administered up to once daily to over
1,780 patients with migraine. Interim hepatic data were reviewed by
an external independent panel of liver experts who concluded that
there was no liver safety signal and compared to placebo arms of
other migraine treatments, there was a very low incidence of
overall elevations of liver laboratory abnormalities (1% incidence
of serum ALT or AST > 3x the upper limit of normal (ULN) through
the data analysis cut-off date).
Biohaven, for the first time, also reported the safety and
preliminary efficacy data from the scheduled dosing cohort. In this
cohort of patients with a history of 4 to 14 moderate to severe
migraine attacks per month, patients were treated with rimegepant
75 mg every other day for up to 12 consecutive weeks. Patients in
this cohort could also supplement their scheduled rimegepant dosing
with additional as-needed (or PRN) dosing on nonscheduled dosing
days. In this cohort, 286 patients received a total of 11,296 doses
of rimegepant 75 mg tablets at least every other day, with median
number of tablets per 4 week period of 14.2. During the
on-treatment period, no rimegepant-treated patients (N=281)
experienced ALT or AST levels >3x the ULN. There were also no
rimegepant-treated patients who experienced alkaline phosphatase or
bilirubin >2x the ULN. With regard to efficacy, 48.4% of
subjects in the scheduled dosing cohort experienced a ≥50%
reduction in the frequency of monthly migraine days with
moderate-to-severe pain intensity during the third month of
treatment.
The company also presented the first clinical reports suggesting
that oral rimegepant has the potential to be safe and consistently
effective for the treatment of breakthrough migraine attacks in
patients taking injectable CGRP-targeting monoclonal antibody (mAb)
preventive therapy. One patient prescribed erenumab and another
taking fremanezumab for prevention successfully treated
breakthrough migraine attacks with oral rimegepant 75 mg without
requiring additional acute treatments during those episodes. No
treatment-related adverse events (AEs) occurred with oral
rimegepant in combination with erenumab or fremanezumab in these
two patients. These cases report that use of oral rimegepant
treated breakthrough migraine attacks in patients taking mAbs with
different mechanisms of action: erenumab targets the CGRP receptor
while fremanezumab targets the circulating CGRP ligand.
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. Rimegepant
represents a novel mechanism that targets the underlying
pathophysiology of migraine without causing vasoconstriction. The
efficacy and safety profile of rimegepant for the acute treatment
of migraine has now been established across four randomized
controlled trials to date: the 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 U.S. Food
and Drug Administration (FDA).
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 potential of rimegepant to be a safe and
effective treatment for breakthrough migraine attacks in certain
patient populations, 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," "planned" 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.