NEW HAVEN, Conn., Feb. 10, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today reported
negative topline results from its Phase 3 clinical trial evaluating
troriluzole compared to placebo for the treatment of patients with
Generalized Anxiety Disorder (GAD). This eight-week trial
randomized 402 adult patients equally at more than 45 centers
in the United States. In this
trial, troriluzole monotherapy at 100mg twice daily did not
differentiate from placebo on the primary endpoint of the mean
change from baseline on the Hamilton Anxiety Rating Scale (HAM-A)
after eight weeks of treatment.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, "While these efficacy results were
disappointing and do not support continued development of
troriliuzole as a monotherapy in GAD, we have multiple ongoing
studies evaluating troriluzole in other disease indications and
with different dosing paradigms. Since it is often difficult to
predict clinical outcomes from preclinical and early clinical proof
of concept studies, our strategy has been to test troriluzole in
four distinct disorders where glutamate has been implicated in the
underlying pathophysiology of the illnesses. We eagerly await
topline data from our adjunctive therapy trial in OCD, and our
symptomatic treatment trials in Alzheimer's disease and
Spinocerebellar Ataxia. We thank the patients and clinical
investigators who participated in the GAD program and sincerely
appreciate all that they have done to see this study through
completion."
After eight weeks of treatment, troriluzole treated subjects had
a mean improvement change from baseline of -9.28 points [95% CI:
-10.23 to -8.32] on the HAM-A total score versus -9.35 points [95%
CI: -10.34 to -8.36] on placebo, p-value = 0.917. Troriluzole was
well tolerated with a low discontinuation rate due to adverse
events (troriluzole 4% versus placebo 4.5%).
Loren Aguiar, M.D., Vice
President of Research and Development stated, "Although the
efficacy results are disappointing, the team conducted a
well-designed study that provided us with definitive data. We are
grateful to the community of patients and researchers who
participated in this trial and allowed us to efficiently enroll the
study in under 10 months."
Biohaven has a deep and broad portfolio of assets in development
with five ongoing Phase 3 trials across it its calcitonin
gene-related peptide (CGRP) antagonists, glutamate modulators and
myeloperoxidase inhibitor platforms. Biohaven continues to prepare
for potential launch with its upcoming 1Q2020 PDUFA date for
rimegepant and expects topline data from the rimegepant prevention
trial in 1Q2020. Earlier this year, troriluzole dosed at 280mg
successfully advanced past an interim futility analysis in its
pivotal Phase 2/3 trial in Alzheimer's disease study performed
after 100 subjects completed 6 months of treatment.
Completion of the troriluzole in Alzheimer's Disease trial is
expected in 4Q2020, and topline data is anticipated from the
troriluzole adjunctive therapy obsessive compulsive disorder (OCD)
trial in 2Q2020 and from the troriluzole in SCA trial in 2021.
Additionally, Biohaven's verdiperstat trial in Multiple System
Atrophy (MSA) is enrolling ahead of schedule with topline results
expected in 2021.
About Troriluzole
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 normalizing 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
troriluzole can be found at the Company's website
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, 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, the possible benefits of troriluzole compared to current
standard of care for GAD patients, as well as the timetable for the
topline data and completion of trials, 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
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 September 30, 2019, filed with the Securities and
Exchange Commission on November 1,
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
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.