NEW HAVEN, Conn., Sept. 27, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced
results from a focused analysis of a clinical trial of verdiperstat
in multiple system atrophy (MSA). Verdiperstat did not
statistically differentiate from placebo on the prespecified
primary efficacy measure, nor on the key secondary efficacy
measures. Initial analysis of safety data was consistent with the
overall profile of verdiperstat from prior clinical trial
experience. Additional analyses are still pending, and full study
results will be presented at an upcoming scientific meeting.
Irfan Qureshi, M.D., Vice
President of Neurology at Biohaven commented, "While we are
disappointed that verdiperstat did not demonstrate efficacy for the
treatment of MSA, Biohaven remains committed to fighting on behalf
of people living with neurodegenerative diseases. There are
currently no approved disease modifying therapies for MSA and we
must continue to advance the science to improve treatment outcomes
for patients suffering from this disease. We are extremely grateful
to the international MSA community – especially the patients and
their families, investigators and their teams, and patient advocacy
groups – who made the trial possible."
Verdiperstat is an investigational first-in-class, potent,
selective, brain-penetrant, and irreversible myeloperoxidase (MPO)
enzyme inhibitor that Biohaven is developing for the treatment of
neurodegenerative diseases. Verdiperstat may help preserve neurons
through inhibition of MPO-induced pathological oxidative stress and
further inflammation that contribute to cellular injury in
neurodegenerative disease.
Although the mechanism of action for verdiperstat,
myeloperoxidase inhibition, was shown not to be effective for MSA,
the rationale of targeting brain inflammation remains strong in
other disease states. An ongoing clinical trial evaluating
the efficacy of verdiperstat in amyotrophic lateral sclerosis (ALS)
is being conducted in collaboration with the Sean M. Healey &
AMG Center for ALS at Massachusetts General Hospital and is
expected to complete enrollment in the fourth quarter of 2021.
About MSA
MSA is a rare, rapidly progressive, severely debilitating, and
fatal neurodegenerative disease that leads to death within a median
of 6-10 years after the onset of symptoms. Manifestations of MSA
can include urinary and sexual dysfunction, dizziness and fainting
due to low blood pressure (orthostatic hypotension), and motor
impairments such as tremor, rigidity, unsteady gait, and difficulty
speaking and swallowing. The most common causes of death in MSA are
infection and cardiopulmonary complications. Currently, patients
receive only symptomatic and palliative therapies as there are no
disease-modifying treatments and no cure for MSA.
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 and preventive
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 MPO inhibition
for neurodegenerative disease, including ALS. 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. The use of certain words,
including the "expect" and "will" and similar expressions are
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 uncertainties relating to the future clinical
success of verdiperstat. 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 for the year ended December 31, 2020, filed with the Securities and
Exchange Commission on March 1, 2021,
and in Biohaven's subsequent filings with the Securities and
Exchange Commission. 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:
Vlad Coric, M.D.
Chief Executive Officer
Vlad.Coric@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.