NEW HAVEN, Conn., Jan. 23, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven")
announced today the U.S. Food and Drug Administration (FDA) has
notified the Company that it may proceed with its clinical
investigation of BHV-3241, a novel myeloperoxidase (MPO) inhibitor,
which Biohaven is developing as a potential treatment for multiple
system atrophy (MSA). The FDA May Proceed Letter was received
following Biohaven's reactivation of the investigational new drug
(IND) application initially filed by AstraZeneca prior to licensing
the compound to Biohaven.
BHV-3241 is a potential first-in-class, oral, brain-penetrant,
irreversible inhibitor of MPO, an enzyme that acts as a key driver
of pathological oxidative stress and inflammation in the brain. MPO
inhibition is a promising therapeutic strategy for treating a
number of neurodegenerative diseases, including MSA.
Vlad Coric, M.D., CEO of
Biohaven, said, "We are very pleased to report the FDA's acceptance
of the IND for BHV-3241 for the treatment of MSA. We believe
BHV-3241 has the potential to be the first effective treatment for
people living with MSA and expect to start our Phase 3 trial in the
third quarter of 2019."
MSA is a rare, rapidly progressive, and fatal neurodegenerative
disease that leads to death after an average of 6 to 10 years from
disease onset. MSA causes Parkinson's disease-like movement
problems (e.g., 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. There is no cure for MSA. Only symptomatic
and palliative therapies are available.
Irfan Qureshi, M.D., Executive
Director of Neurology at Biohaven, commented, "People living with
MSA urgently need new therapies. BHV-3241 offers the potential to
treat MSA by inhibiting myeloperoxidase enzyme activity, thereby
alleviating oxidative stress and neuroinflammation." He added,
"AstraZeneca's Phase 2 clinical trial suggested that BHV-3241 may
have reduced MSA disease progression in a dose-dependent manner,
measured by the Unified MSA Rating Scale. We are excited to advance
into a Phase 3 trial to assess the efficacy of BHV-3241 for the
treatment of MSA."
About BHV-3241
BHV-3241 is a potential first-in-class, oral, brain-penetrant,
irreversible inhibitor of MPO, which Biohaven is developing as a
treatment for MSA. BHV-3241 also has the potential to be developed
in a number of other disease indications associated with oxidative
stress, inflammation, and neurodegeneration. Approximately 250
healthy volunteers and patients have been treated with BHV-3241 in
Phase 1 and Phase 2 clinical trials performed by AstraZeneca.
Results from a Phase 2 trial in MSA showed evidence of target
engagement and favorable trends over 12 weeks on the Unified MSA
Rating Scale, an exploratory clinical outcome measure. Biohaven
licensed BHV-3241 from AstraZeneca in September 2018, where it was known as
AZD3241.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a
portfolio of innovative, late-stage product candidates targeting
neurological diseases. Biohaven combines internal development and
research with intellectual property licensed from companies and
institutions including Bristol-Myers Squibb Company, AstraZeneca
AB, Yale University, Catalent, ALS
Biopharma LLC and Massachusetts General Hospital. 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, including the Company's plans for the clinical
development and potential regulatory approval and commercialization
of BHV-3241 and other product candidates for various neurological
conditions, the potential for BHV-3241 to be an effective treatment
for neurodegenerative disorders including multiple system atrophy
and the potential for BHV-3241 to be a first-in-class treatment for
multiple system atrophy, are forward-looking statements. The use of
certain words, including "potential", "believe", "could", "expect",
"may" 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
BHV-3241, and whether the results observed in AstraZeneca's prior
studies and clinical trials of BHV-3241 will be observed in
Biohaven's future clinical trials of BHV-3241 in various
neurodegenerative disorders, including those beyond multiple system
atrophy. Additional important factors to be considered in
connection with forward-looking statements are described in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
November 14, 2018. 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.
For further information, contact Dr. Vlad Coric, the Chief Executive Officer at
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.