NEW HAVEN, Conn., Sept. 10, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a
commercial-stage biopharmaceutical company with a portfolio of
innovative, late-stage product candidates targeting neurological
and neuropsychiatric diseases, today reported that the U.S. Food
and Drug Administration (FDA) has authorized the initiation of
clinical trials for oral zavegepant (formerly BHV-3500) and that
the company has achieved first in human dosing in a Phase 1 trial
designed to assess the safety and pharmacokinetics of oral
formulations of zavegepant.
Biohaven recently announced securing up to $250 million in funding to advance the company's
CGRP receptor antagonist program through the development of
zavegepant. The zavegepant program encompasses intranasal
zavegepant as well as oral formulations of zavegepant for migraine
and non-migraine indications. Intranasal zavegepant previously
demonstrated superior efficacy to placebo in a Phase 2/3 study for
the acute treatment of migraine and the investigational agent is
also being studied in an ongoing double blind, randomized,
placebo-controlled trial in COVID-19 infected hospitalized patients
requiring supplemental oxygen.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "We are excited to advance the oral
formulations of zavegepant into human studies and broaden our CGRP
franchise into migraine adjacencies, non-migraine indications and
new formulations across the globe. Our team has developed a deep
knowledge of the receptor kinetics and pharmacology of the CGRP
pathways, and our intention is to expand our CGRP targeting agents
across a number of neuroimmune disorders."
Charles Conway, Ph.D., Chief
Scientific Officer commented, "zavegepant has unique chemical
properties and is a structurally distinct CGRP receptor antagonist
that allows for administration in a variety of formulations.
Zavegepant provides an opportunity to expand our CGRP program
with customization of our products to different disease states
based on the distinct attributes of each agent and
formulation."
About Zavegepant
Zavegepant is a third generation,
high affinity, selective and structurally unique, small molecule
CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine
Platform and the only CGRP receptor antagonist in clinical
development with both intranasal and oral formulations. The
efficacy and safety profile of intranasal zavegepant for the acute
treatment of migraine, as compared to placebo, was shown in a
randomized controlled Phase 2/3 dose-ranging trial with a total of
over 1000 patients who received zavegepant. In this study,
zavegepant showed statistical superiority to placebo on the
coprimary endpoints of 2 hour freedom from pain and freedom from a
patients' most bothersome symptom (either nausea, photophobia or
phonophobia). Following successful end of Phase 2 interactions with
FDA (clinical and nonclinical), zavegepant is advancing to Phase 3
for the acute treatment of migraine in adults. More information
about zavegepant can be found on the Biohaven website:
https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.
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 news 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
zavegepant as an acute treatment for patients with migraine.
Factors that could affect these forward-looking statements include
those related to: Biohaven's ability to effectively commercialize
zavegepant, delays or problems in the supply or manufacture of
zavegepant, 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 June 30, 2020 filed with the Securities and
Exchange Commission on August 10,
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
NOJECTION and NURTEC are trademarks of Biohaven Pharmaceutical
Ireland DAC.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.