NEW HAVEN, Conn., Nov. 5, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) a clinical-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological and
neuropsychiatric diseases, today announced that it has completed
enrollment in the T2 Protect AD Study, a Phase 2/3 clinical trial
of troriluzole in Alzheimer's disease. An interim futility analysis
examining standard cognitive assessments and volumetric magnetic
resonance imaging (MRI) is expected before the end of 2019.
"We are hopeful this study will demonstrate that troriluzole can
ameliorate the symptoms of Alzheimer's disease, by reducing
synaptic glutamate through a novel mechanism of action," said
Howard Feldman, MD, FRCP(C),
Director of the Alzheimer's Disease Cooperative Study
(ADCS) and Professor of Neurosciences at the University of
California San Diego School of Medicine, who is Principal
Investigator of the T2 Protect AD Study. "Glutamate is one of the
only clinically validated therapeutic targets for Alzheimer's
disease."
The T2 Protect AD Study (clinicaltrials.gov identifier
NCT03605667) is a Phase 2/3, randomized, double-blind,
placebo-controlled trial evaluating the efficacy and safety of
troriluzole in patients diagnosed with Alzheimer's disease of
mild-to-moderate severity (Mini-Mental State Examination scores of
14-24). Patients are randomized on a 1:1 basis to receive 280 mg of
troriluzole or placebo once daily for 48 weeks. The trial is being
conducted in collaboration with the ADCS at UC San Diego School of
Medicine. More information about the trial can be found at the
website: http://www.t2protect.org/
Vlad Coric, M.D., CEO of Biohaven
commented, "Given the devastating impact of Alzheimer's disease on
patients, their families and the healthcare system, we need to
urgently assess novel treatment interventions targeting the
underlying pathophysiology of this illness. We are grateful to the
ADCS and patients participating in our trial to assess the
potential efficacy of our glutamate modulator, troriluzole, in this
illness."
Alzheimer's disease is a progressive, fatal neurodegenerative
dementia that accounts for 60 to 80 percent of dementia cases.
Alzheimer's disease currently has no cure. Although there are
FDA-approved medications for symptomatic treatment, their clinical
benefits are generally limited.
"We are extremely grateful to all the trial participants and
their families, as well as our trial sites, for helping us achieve
this milestone," commented Irfan
Qureshi, MD, Vice President of Neurology at Biohaven. "We
believe that troriluzole is a promising potential therapy for
people suffering from Alzheimer's disease and look forward to the
study results, including the interim analysis by the end of
this year."
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 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: 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.
About ADCS
The Alzheimer's Disease Cooperative Study (ADCS) at the
University of California San Diego is
an academic research organization that promotes the discovery and
testing of new drugs for the treatment of Alzheimer's disease. ADCS
was developed in response to an urgent need to advance research in
the development of drugs that might be useful for treating patients
across the spectrum of Alzheimer's disease.
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 2/3 trial of troriluzole in AD, the potential
results of the Company's Phase 2/3 trial of troriluzole in AD, the
potential role of glutamate in AD, the possible benefits of
troriluzole for AD patients, as well as the size of the potential
market for troriluzole in AD, 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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.