NEW
HAVEN, Conn., Sept. 29,
2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN) today announced results from a focused
analysis of treatment with verdiperstat in the HEALEY ALS Platform
Trial in amyotrophic lateral sclerosis (ALS). The HEALEY ALS
Platform Trial, the first-ever platform trial in ALS, is designed
as an adaptive trial to evaluate multiple investigational
treatments simultaneously, thus accelerating the development of
effective and breakthrough treatments for people living with
ALS.
Verdiperstat did not statistically differentiate from placebo on
the prespecified primary efficacy outcome, disease progression
measured by the ALS Functional Rating Scale-Revised and survival,
nor the key secondary efficacy measures during the 24-week study
period. Initial analysis of safety data was consistent with the
overall profile of verdiperstat from prior clinical trial
experience. Additional analyses are ongoing, and complete study
results will be presented at an upcoming scientific meeting.
Irfan Qureshi, M.D., Senior Vice
President of Neurology at Biohaven, stated, "We are incredibly
grateful to our collaborators at the Sean M. Healey & AMG
Center for ALS at Massachusetts General Hospital, HEALEY ALS
Platform Trial study investigators, and the ALS community –
especially people with ALS and their families –– who made the trial
possible. While we are disappointed that verdiperstat did not
demonstrate efficacy for ALS, Biohaven remains committed to
developing treatments for people who suffer from neurodegenerative
diseases."
About ALS
ALS is a progressive, life-threatening, and
rare neuromuscular disease that affects approximately 30,000 people
in the United States. The median
age of onset is 55 years and average survival is 3-5 years after
onset of first symptoms. ALS is characterized by the loss of motor
neurons in the brain, brainstem, and spinal cord that leads to
progressive muscle weakness and difficulties in speaking,
swallowing, and breathing. There are currently limited treatment
options and no cure for ALS.
About Biohaven
Biohaven is a global 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 and preventive
treatment of migraine (EMA-approved as Vydura™ (rimegepant) for the
acute treatment of migraine with or without aura, and prophylaxis
of episodic migraine in adults who have at least four migraine
attacks per month) and a broad pipeline of late-stage product
candidates across five distinct mechanistic platforms: CGRP
receptor antagonism for the acute and preventive treatment of
migraine; glutamate modulation for obsessive-compulsive disorder
and spinocerebellar ataxia; and MPO inhibition for amyotrophic
lateral sclerosis; Kv7 Ion Channel Activators (Kv7) for focal
epilepsy and neuronal hyperexcitability, and myostatin inhibition
for neuromuscular diseases. 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", "anticipate",
"expect" 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 verdiperstat as a treatment for
patients with ALS. Factors that could affect these forward-looking
statements include those related to Biohaven's ability to
effectively develop verdiperstat. Various important factors could
cause actual results or events to differ materially from those that
may be expressed or implied by 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 25, 2022, and in Biohaven's subsequent
filings with the Securities and Exchange Commission. The
forward-looking statements are made as of the date of this new
release, 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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC. VYDURA is a trademark of Biohaven
Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of
Biohaven Pharmaceutical Holding Company Ltd.
Biohaven Contact:
Jennifer
Porcelli
VP, Investor Relations
Jennifer.porcelli@biohavenpharma.com
Media Contact:
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.