NEW HAVEN, Conn., Sept. 18, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the
"Company"), a clinical stage biopharmaceutical company with a
portfolio of late-stage product candidates for neurological and
neuropsychiatric diseases, announced today that the Company's
myeloperoxidase (MPO) inhibitor, verdiperstat, has been selected as
an investigational therapy in the first Amyotrophic Lateral
Sclerosis (ALS) platform trial, an innovative program designed by
the Sean M. Healey & AMG Center for ALS at Mass General to help
accelerate a path to new and effective ALS treatments.
Verdiperstat is a potential first-in-class, oral,
brain-penetrant, irreversible inhibitor of the MPO enzyme. MPO is
believed to play an important role in multiple neurodegenerative
diseases, because it increases oxidative stress and inflammation
levels in the brain. Inhibiting MPO is anticipated to ameliorate
these pathological mechanisms, which are strongly implicated in the
onset and progression of ALS, a progressive and fatal
neurodegenerative disease with limited treatment options.
The HEALEY ALS Platform Trial is being conducted by leading ALS
experts from the Healey Center in collaboration with the Northeast
ALS Consortium (NEALS) clinical trial network and TackleALS.
Promising investigational drugs for the HEALEY ALS Platform Trial
were chosen through a competitive process, with the Healey Center
providing partial financial support to successful applicants.
An independent advisory council selected verdiperstat for inclusion
in the platform based on a thorough scientific and clinical
review.
Merit Cudkowicz, MD, MSc, Director of the Healey Center, Chief
of Neurology at MGH, and co-founder of NEALS commented, "We are
excited to accelerate how therapies are developed for people with
ALS. We are in a new era for ALS therapy development and we must
think differently and boldly about how to find effective treatments
for our patients."
The HEALEY ALS Platform Trial is a major innovation in the field
of ALS drug development that is aimed at accelerating the
identification of effective new treatments. In contrast with
traditional trials that typically evaluate only one drug at a time,
platform trials create an infrastructure for the ongoing study of
multiple investigational drugs in parallel using specialized
statistical methods. This approach helps to maximize resources and
efficiency. The Food and Drug Administration is now strongly
encouraging the use of innovative clinical trial designs, such as
platform trials, which can be used to provide substantial evidence
of clinical efficacy to support a drug approval. More information
about the HEALEY ALS Platform Trial can be found at
www.massgeneral.org/als.
"We are extremely pleased to have the opportunity to study
myeloperoxidase inhibition with verdiperstat as a novel therapeutic
approach for people with ALS," said Irfan
Qureshi, MD, Biohaven Vice President and Development Lead
for verdiperstat. "This study would not be possible on these
timelines without the support and collaboration of the HEALEY ALS
Platform Trial."
About Verdiperstat
Biohaven licensed verdiperstat
(BHV-3241) from AstraZeneca in September
2018, where it was known as AZD3241. Approximately 250
healthy volunteers and patients have been treated with verdiperstat
in Phase 1 and Phase 2 clinical trials. A Phase 3 clinical trial is
currently ongoing to evaluate the efficacy of verdiperstat in
Multiple System Atrophy (MSA), a rare, progressive and fatal
neurodegenerative disease. Additional details about the trial
(NCT03952806) can be found at www.clinicaltrials.gov.
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, Yale University, Catalent,
Rutgers, and ALS Biopharma LLC.
Currently, Biohaven's lead development programs include multiple
compounds across its CGRP receptor antagonist, glutamate
modulation, and myeloperoxidase inhibitor platforms. Biohaven's
common shares are listed on the New York Stock Exchange and traded
under the ticker symbol BHVN. 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 effectiveness and safety
of verdiperstat, the expected timing, commencement and outcomes of
the Company'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 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" 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 and the Company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2019, filed
with the Securities and Exchange Commission on August 9, 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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.