NEW HAVEN, Conn., May 7, 2019 /PRNewswire/ -- (NYSE: BHVN) -
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today
announced continued progress in its glutamate modulating platform
with enrollment expected to complete in three Phase 2/3 clinical
trials of troriluzole in Alzheimer's disease, generalized anxiety
disorder and obsessive-compulsive disorder by the end of
2019. Enrollment in the spinocerebellar ataxia Phase 3
clinical trial is expected to complete by the first quarter of
2020. In addition, the first Phase 3 trial from the company's
myeloperoxidase (MPO) inhibition platform is set to begin by the
third quarter of 2019. The study of verdiperstat will examine
efficacy and safety of the drug in multiple system atrophy (MSA).
"We continue to advance our late stage assets targeting some of
the most disabling neurodegenerative and neuropsychiatric disorders
with our novel drug candidates. Our neuroinnovation platforms are
evaluating the next generation of treatments for diseases in which
there are currently limited or no treatments available," said
Vlad Coric, M.D., Chief Executive
Officer of Biohaven. "We are looking to efficiently advance these
candidates through the clinic and work with regulatory agencies to
provide new treatment options for patients with devastating
neurological conditions."
Troriluzole, a product candidate in Biohaven's glutamate
modulation platform, which modulates the brain chemical glutamate,
is currently being studied in four ongoing clinical trials that are
expected to complete enrollment this year:
- The Phase 2/3 clinical trial of troriluzole in Alzheimer's
disease, which has already enrolled over 100 patients.
- A Phase 3 clinical trial of troriluzole in SCA, an inherited
form of ataxia, a rare and progressive neurological disease.
- A Phase 2/3 clinical of troriluzole in generalized anxiety
disorder.
- A Phase 2/3 clinical of troriluzole in obsessive-compulsive
disorder.
Additionally, Biohaven's first clinical trial from its MPO
platform for verdiperstat (formerly known as BHV-3241) is expected
to enter a Phase 3 clinical trial in MSA in the third quarter of
2019. A previous Phase 2 clinical trial of Verdiperstat was
observed to be generally well tolerated in a previous Phase 2
clinical trial of patients with MSA, with numerical improvements on
the change from baseline Unified MSA Rating Scale.
Patients with MSA have a life expectancy of 6 to 10
years from the time of symptom onset and there are currently no
disease modifying treatments available for MSA.
Beyond neurological indications, Biohaven continues to advance
the University of Connecticut
collaboration as the metallothionein (MT) program non-clinical
program supports lead molecule selection.
About Biohaven's Glutamate Modulation Platform
Biohaven's glutamate modulation platform is comprised of
candidates that are designed to balance the glutamate system.
Glutamate is an important neurotransmitter present in over 90
percent of all brain synapses and is a naturally occurring molecule
that nerve cells use to send signals to other cells in the central
nervous system. Glutamate plays an essential role in normal brain
functioning and its tight regulation is critical to its proper
brain function. Abnormal glutamate release is known to disrupt
nerve health, potentially leading to neuronal cell death which is
associated with devastating neurogenerative diseases such as
amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia
(SCA), Alzheimer's disease (AD), anxiety, depression,
obsessive-compulsive disorder (OCD), chronic pain, and a variety of
cancers. Modulating glutamate has the potential to be
neuroprotective and increase the release of neurotrophic factors,
including brain derived neurotrophic factor, which are endogenous
molecules that help to support the survival of existing neurons,
and encourage the growth and differentiation of new neurons and
synapses.
About Biohaven's Myeloperoxidase (MPO) Inhibition
Platform
Myeloperoxidase (MPO) is one of the most important enzymes for
generative oxidative stress and inflammation. MPO levels are
increased in a range of brain disorders, and inhibition of MPO
activity may reduce production of oxidants that feed
neuroinflammatory processes, thereby slowing progression of several
neurodegenerative diseases, including MSA. Studies have also linked
increased MPO levels with multiple sclerosis and Alzheimer's
disease.
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, 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
inhibition platforms. 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 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. 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, Chief Executive Officer,
at Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.