NEW HAVEN, Conn., July 22, 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 enrollment in the
T2 Protect AD Study, a Phase 2/3 clinical trial of troriluzole in
Alzheimer's disease, is progressing on timelines with more than 400
subjects enrolled (for screening) and over 180 subjects randomized
to study treatment (troriluzole or placebo). The trial is expected
to be fully enrolled before the end of 4Q2019.
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). Approximately 340 patients will be randomized on a 1:1
basis to receive 280 mg of troriluzole or placebo once daily.
Duration of treatment is 48 weeks. The trial is being conducted in
collaboration with the Alzheimer's Disease Cooperative Study
(ADCS). More information about the trial can be found at the
website: http://www.t2protect.org/
Howard Feldman, MD, FRCP(C),
Director of the ADCS and Professor of Neurosciences, University of
California, San Diego, who is serving as Principal Investigator of
the T2 Protect AD Study stated, "We are happy to report enrollment
is on track. We look forward to performing the pre-planned interim
futility analysis by the end of this year."
Alzheimer's disease is a progressive, fatal neurodegenerative
dementia that accounts for 60 – 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.
"Glutamate modulation is one of the only clinically validated
therapeutic mechanisms in Alzheimer's disease," said Irfan Qureshi, MD, Executive Director of
Neurology at Biohaven. "Troriluzole offers a novel and potentially
robust therapeutic approach aimed at normalizing glutamate levels
that may improve cognitive symptoms in people suffering from
Alzheimer's disease."
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, 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.
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
regarding the Company's business and product candidate plans and
objectives are forward-looking statements. Forward-looking
statements include those related to: the effectiveness and safety
of troriluzole, 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 and the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, filed
with the Securities and Exchange Commission on May 8, 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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.