NEW HAVEN, Conn., Jan. 4, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") today
announced that it has commenced enrollment in a Phase 3 clinical
trial assessing the efficacy and safety of troriluzole in patients
with obsessive-compulsive disorder (OCD). Biohaven is advancing the
280 mg once daily dose of troriluzole into two double-blind,
placebo-controlled Phase 3 clinical trials with identical study
designs and plans to enroll approximately 600 patients in each of
these adjunctive treatment trials across study sites in both
the United States and
Europe. A prior proof of concept study with adjunctive
troriluzole in patients with OCD showed a clinically meaningful
effect at all study timepoints in patients who had an inadequate
response to existing standard of care treatment. Although the study
sample size in Phase 2 did not demonstrate statistical
significance, the data from the previous trial was instrumental in
refining and powering the Phase 3 studies.
Elyse Stock, M.D., Chief Medical
Officer commented, "We look forward to advancing our Phase 3
clinical trials of troriluzole 280 mg for the adjunctive treatment
of OCD. If approved, this would provide hope to many who suffer
with OCD and for whom standard of care medications do not provide
adequate relief. No new treatments for OCD have been approved
for over two decades. With its novel mechanism of action
compared to currently available therapies, troriluzole would
provide a significant advance in treatment for the many patients
who either do not respond or continue to experience residual
symptoms with standard medications."
Troriluzole is a new chemical entity and third-generation
glutamate modulating agent that normalizes glutamate, a key
neurotransmitter implicated in obsessive-compulsive
disorder. Biohaven was awarded two U.S. Patents
covering troriluzole, with international patents pending, all
having statutory expiration dates in 2039. The primary mechanism of
action of troriluzole is enhancing synaptic glutamate cycling by
augmenting the expression and function of excitatory amino acid
transporters (i.e., EAAT1-2) located on glial cells that play a key
role in clearing glutamate from the synapse. Glutamatergic
dysfunction is implicated in the pathophysiology of a broad range
of disorders including OCD, Amyotrophic Lateral Sclerosis,
Spinocerebellar Ataxia, Alzheimer's Disease, depression, chronic
pain, and a variety of cancers. The therapeutic potential of
troriluzole is supported by clinical and translational research
studies.
Loren Aguiar, M.D., Vice
President, Research and Development stated, "We are pleased to
initiate our first Phase 3 study to advance the development of
troriluzole in OCD. The prior proof-of-concept study provided
valuable data for us to adequately power and design the Phase 3
studies. We are excited to begin these new studies as
approximately one third of patients with OCD do not respond to
currently available medications and new therapies are urgently
needed. We believe troriluzole, which normalizes neuronal
glutamate, could offer a promising alternative treatment with a new
mechanism of action for OCD sufferers who are not adequately
responding to currently available treatments."
OCD is a serious psychiatric condition affecting over 2 million
individuals in the U.S. and significantly impacts quality of
life. It is a chronic and long-lasting disorder in which a
person has uncontrollable, reoccurring thoughts (obsessions) and
behaviors (compulsions). The current standards of care include
behavioral therapy and selective serotonin reuptake inhibitors. It
is estimated that 20-30% of OCD sufferers derive minimal benefit
from current treatment options and continue to experience
significant residual symptoms despite currently approved
therapies.
Jeff Szymanski, PhD, Executive
Director, International OCD Foundation added, "There is a
significant need for new treatments for those suffering from OCD.
We applaud Biohaven for their ongoing research and moving forward
with these upcoming trials."
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. Our progress is fueled by an
entrepreneurial organizational structure and an impressive range of
experience in drug development along with the confident support of
top-tier biopharma investors. 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. The use of certain words,
including the "believe" 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 troriluzole. 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, 2019, filed with the Securities and
Exchange Commission on February 26,
2020 and Biohaven's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020
filed with the Securities and Exchange Commission on November 9, 2020. 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.
For further information, contact:
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.