NEW HAVEN, Conn., July 31, 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 it enrolled the
first patient in a Phase 3 clinical trial to evaluate the efficacy
and safety of verdiperstat in subjects with Multiple System Atrophy
("MSA").
Verdiperstat is a potential first-in-class, oral,
brain-penetrant, irreversible inhibitor of myeloperoxidase, an
enzyme that acts as a key driver of pathological oxidative stress
and inflammation in the brain. Results from a previous Phase 2
trial in MSA completed by AstraZeneca AB showed evidence of target
engagement and favorable trends over 12 weeks on the Unified MSA
Rating Scale, an exploratory clinical outcome measure. Verdiperstat
has received orphan drug designation for the treatment of MSA from
the FDA Office of Orphan Products Development as well as the
European Commission upon recommendation from the European Medicines
Agency's Committee for Orphan Medicinal Products.
"We are so pleased to partner with Biohaven in building hope for
the patients and families affected by this devastating disease.
This clinical trial presents an exciting opportunity to empower
people living with MSA by playing an active role in research,"
commented Pamela Bower of the MSA
Coalition. "We are grateful for Biohaven's commitment to joining
our community in standing up against MSA!" added Philip Fortier of Defeat MSA. More information
about the MSA Coalition and Defeat MSA is available
at www.multiplesystematrophy.org and
www.defeatmsa.org.
MSA is a rare, rapidly progressive, and fatal neurodegenerative
disease. Only symptomatic and palliative therapies are currently
available. MSA causes Parkinson's disease-like movement problems
(slow movement, rigid muscles, tremor, and poor balance),
cerebellar ataxia, as well as problems with involuntary (autonomic)
functions, including blood pressure control, bladder function, and
digestion. MSA usually leads to death after an average of 6 to 10
years from the onset of symptoms.
Irfan Qureshi, MD, Biohaven Vice
President and Development Lead for Verdiperstat, commented,
"Verdiperstat is the first product candidate from Biohaven's
neuroinflammation platform and highlights our commitment to
developing innovative medicines for neurological diseases with high
unmet need."
Biohaven expects to recruit approximately 250 patients in the
study, across approximately 50 sites in the United States and Europe. The study will enroll subjects with
MSA diagnosed using consensus clinical criteria and
include both subtypes of MSA, MSA-Parkinsonism (MSA-P) and
MSA-Cerebellar (MSA-C). Researchers will evaluate the efficacy
of verdiperstat, compared to placebo, as measured by a change from
baseline in a modified version of the Unified MSA Rating Scale
(UMSARS) at Week 48. Additional details about the trial
(NCT03952806) can be found at www.clinicaltrials.gov.
Jeremy D. Schmahmann, MD,
Professor of Neurology at Harvard Medical
School and Founding Director of the Massachusetts General
Hospital Ataxia Unit, stated, "We are excited to have enrolled the
first patient in this study. Working together with our patients and
the Biohaven team, we are optimistic that this is the beginning of
a new era of treatment and eventually cure for this challenging
neurodegenerative disorder."
About Verdiperstat
Biohaven licensed verdiperstat
(BHV-3241) from AstraZeneca AB in September
2018, where it was known as AZD3241. Approximately 250
healthy volunteers and patients were treated with verdiperstat in
Phase 1 and Phase 2 clinical trials. Results from a Phase 2 trial
in MSA showed evidence of target engagement and favorable trends
over 12 weeks on the UMSARS, an exploratory clinical outcome
measure. Verdiperstat received Orphan Drug designation from the U.S
Food and Drug Association as well as the European Commission due to
the unmet medical need in MSA. Verdiperstat also has the potential
to be developed in a number of other diseases associated with
oxidative stress, inflammation, and neurodegeneration.
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 AB, 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 March 31, 2019, filed
with the Securities and Exchange Commission on May 8, 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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