NEW HAVEN, Conn., Oct. 28, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurologic and
neuropsychiatric diseases, today announced that it has completed
enrollment in its pivotal Phase 3 clinical trial assessing the
efficacy and safety of troriluzole in generalized anxiety disorder
(GAD). This multicenter, randomized, placebo-controlled, trial
enrolled over 880 patients in less than nine months.
GAD is a chronic and long-lasting disorder in which a person has
uncontrollable, excessive anxiety and worry and is often associated
with significant functional impairment. According to the Anxiety
and Depression Association of America (ADAA), millions of Americans
suffer from GAD. If not appropriately treated, GAD has a
chronic course associated with significant disability and high
public burden. The current standard of care includes psychotherapy
and medications including selective serotonin reuptake inhibitors
(SSRIs), serotonin-norepinephrine inhibitors (SNRIs) and
benzodiazepines. It is estimated that only approximately 30% of GAD
sufferers fully respond to SSRI/SNRIs and the use of
benzodiazepines can be associated with abuse, dependence and
withdrawal symptoms.
Vlad Coric, M.D., CEO of Biohaven
commented, "GAD is one of the most prevalent anxiety disorders seen
in both primary care and specialist settings. We are hopeful that
this Phase 3 study will demonstrate troriluzole's novel mechanism
of action as a potential approach for addressing the debilitating
consequences of GAD without the limitations associated with current
treatments."
The primary outcome measure in this 8-week GAD trial with
troriluzole is the change in a patient's score on the Hamilton
Anxiety Rating Scale (HAM-A), a scale designed to assess the
severity and type of symptoms in patients with GAD. The HAM-A is a
widely used and validated scale that has served as the primary
outcome measure to obtain approval in GAD both in the United States and globally. The trial will
also assess the safety, tolerability and pharmacokinetics of
troriluzole. Additional details about the trial can be found
at www.clinicaltrials.gov.
Loren Aguiar, M.D., Vice
President, Research and Development at Biohaven added, "We are
grateful to the patients and clinical trial sites who helped us
complete enrollment in this trial of troriluzole in less than nine
months. The brisk study enrollment reflects the large numbers
of patients who are not satisfied with their response on current
therapies. We believe that troriluzole could be a promising
alternative to current standards of care and look forward to
topline results in the near term."
Troriluzole is a third-generation prodrug and new chemical
entity that modulates glutamate, the most abundant excitatory
neurotransmitter in the human body. The primary mode of action of
troriluzole is reducing synaptic levels of glutamate. Troriluzole
increases glutamate uptake from the synapse, by augmenting the
expression and function of excitatory amino acid transporters
(i.e., EAAT2) located on glial cells that play a key role in
clearing glutamate from the synapse. More information about
trorilzuole can be found at the Company's website link:
https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole
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, including the expected enrollment for the
Company's Phase 3 trial of troriluzole, the potential results of
the Company's Phase 3 trial of troriluzole in GAD, the potential
for the Phase 3 trial to be a pivotal trial, the role of glutamate
in GAD and the possible benefits of troriluzole compared to current
standard of care for GAD patients, as well as the size of the
potential market for troriluzole in GAD, are forward-looking
statements. 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, 2018,
as updated by the Company's subsequent Quarterly Reports on Form
10-Q. 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, Biohaven's Chief Executive Officer
at Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.