NEW HAVEN, Conn., Nov. 16, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a
commercial-stage biopharmaceutical company with a portfolio of
innovative, late-stage product candidates, today announced that Dr.
Richard Granstein, M.D., Chairman of
Dermatology at Weill Cornell Medicine in New York City, will initiate an
investigator-led clinical trial with a Biohaven CGRP-receptor
antagonist for the treatment of plaque psoriasis.
Vlad Coric M.D., Chief Executive
Officer of Biohaven commented, "Biohaven's neuroinnovation
portfolio is powered by a combination of strong science and patient
need. Dr. Granstein is a foremost expert in the CGRP-related
biology of dermatological conditions, which has been a focus of his
research for nearly two decades. We are committed to following the
science of CGRP-receptor antagonism across disease states and Dr.
Granstein's pioneering work affirms that neuropeptide CGRP may play
a critical role in plaque psoriasis. This scientific
foundation, together with a recognized need for more safe and
effective treatment options for people suffering with psoriasis,
has inspired our meaningful collaboration."
The investigator-led clinical trial will explore whether
treatment with one of Biohaven's CGRP-receptor antagonists will
reduce the severity of disease and percentage of area affected as
measured by patients' Psoriasis Activity Severity Index (PASI)
score after 16 weeks of treatment as compared to placebo. In
addition, the study will assess the potential impact on itch and
patient quality-of-life measures.
Dr. Granstein commented, "The animal models and clinical reports
of CGRP in psoriasis suggest that CGRP receptor antagonism could
alleviate the severity of disease. This clinical study will enable
us to evaluate this therapeutic candidate's efficacy, the findings
of which will be the first step in bringing this novel,
translational idea to patients. Pathways by which the nervous
system exerts regulatory effects on immunity may prove to provide
important druggable targets for a range of inflammatory
disorders."
Biohaven's CGRP-receptor antagonist platform includes Nurtec™
ODT (rimegepant) and zavegepant. Nurtec ODT™ was approved by the
FDA in February 2020 for the acute
treatment of migraine. Biohaven filed a supplemental New Drug
Application (sNDA) for Nurtec™ ODT (rimegepant) for the preventive
treatment of migraine earlier this year which was accepted for
review in October 2020. The
Prescription Drug User Fee Act (PDUFA) goal date for completion of
the FDA review of the preventive sNDA is set for 2Q2021.
Zavegepant is a third generation, high affinity, selective
and unique, small molecule CGRP receptor antagonist that is
structurally distinct from rimegepant. Zavegepant may be suitable
for multiple routes of delivery including nasal, subcutaneous,
inhalation or oral administration. Positive results were announced
in late 2019 from a Phase 2/3 study of intranasal zavegepant in the
acute treatment of migraine, and the company plans to initiate an
additional Phase 3 study before the end of 2020. Biohaven also
initiated a Phase 2 trial with intranasal zavegepant in
April 2020 in collaboration with
Thomas Jefferson University in
Philadelphia, PA, to study the
potential benefits of CGRP receptor-blockade in mitigating an
excessive immune response in pulmonary function which in some cases
can be fatal in COVID-19 patients.
About Plaque Psoriasis
Psoriasis is a serious and chronic autoimmune skin disease that
causes cells to develop rapidly on the skin, which affects 7-8
million people in the US alone. This overgrowth leads to formation
of thick, scaly, often painful plaques that can bleed and itch.
Psoriasis affects both men and women and can appear at any age.
Psoriasis has a serious negative impact on patients' lives, often
leading to lost productivity, work absenteeism and significant
modification of daily activities. While the exact cause of
psoriasis is unknown, several different mechanisms may play a role,
as well as genetic and environmental factors. Recent research
suggests that the neuropeptide and vasodilator, CGRP, also
contributes to the regulation of immune and inflammatory processes
within the skin.
About Biohaven
Biohaven is a commercial-stage biopharmaceutical company with a
portfolio of innovative, best-in-class therapies to improve the
lives of patients with debilitating neurological and
neuropsychiatric diseases, including rare disorders. Biohaven's
neuroinnovation portfolio includes FDA-approved NURTEC™ ODT
(rimegepant) for the acute treatment of migraine and a broad
pipeline of late-stage product candidates across three distinct
mechanistic platforms: CGRP receptor antagonism for the acute and
preventive treatment of migraine; glutamate modulation for
obsessive-compulsive disorder, Alzheimer's disease, and
spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for
multiple system atrophy and amyotrophic lateral sclerosis. More
information about Biohaven is available
at www.biohavenpharma.com.
Forward-Looking Statements
This release includes forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. The use of
certain words, including "believe", "continue", "may", "will" and
similar expressions, are intended to identify forward-looking
statements. These forward-looking statements involve substantial
risks and uncertainties, including statements that are based on the
current expectations and assumptions of Biohaven's management about
the potential use of Biohaven's CGRP receptor antagonists as a
treatment for patients with plaque psoriasis. Factors that could
affect these forward-looking statements include those related to:
Biohaven's ability to effectively develop a CGRP receptor
antagonist for the treatment of plaque psoriasis, complying with
applicable U.S. regulatory requirements, the expected
timing, commencement and outcomes of Biohaven'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 Biohaven's product
candidates, the potential for Biohaven's product candidates to be
first in class or best in class therapies and the effectiveness and
safety of Biohaven's product candidates. 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 Biohaven's Annual Report on Form 10-K for
the year ended December 31, 2019,
filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report
on Form 10-Q for the quarter ended September
30, 2020 filed with the Securities and Exchange Commission
on November 9, 2020. The
forward-looking statements are made as of this date and Biohaven
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
NURTEC is a trademark of Biohaven Pharmaceutical Ireland
DAC.
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