NEW HAVEN, Conn., Dec. 6, 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 successful completion of
a pre-planned interim futility analysis for the T2 Protect AD
Study. This study is an ongoing Phase 2/3 clinical trial of
troriluzole in Alzheimer's disease led by the Alzheimer's Disease
Cooperative Study (ADCS) at the University of
California San Diego School of Medicine.
The independent DSMB communicated that futility was not met
based on pre-specified criteria for the interim analysis, which
evaluated standard cognitive assessments and hippocampal volume on
magnetic resonance imaging parameters. The interim analysis was
designed specifically to allow for stopping the trial early due to
futility. In order to pass the interim futility analysis,
troriluzole had to demonstrate numerically greater benefit over
placebo on at least one of the two pre-specified criteria at 26
weeks: either (i) cognitive function as measured by the ADAS-cog or
(ii) hippocampal volume as assessed by magnetic resonance imaging.
Biohaven announced that based upon the interim futility and safety
analysis performed by the independent DMSB that the study would
continue.
Howard Feldman, MD, FRCP(C),
Director of the 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, commented,
"Given the tremendous burden of Alzheimer's disease on patients and
families, as well as public health, it is imperative that we
rapidly and efficiently study promising new treatments such as
troriluzole." Dr. Feldman added, "We are very pleased the interim
futility analysis supports continuation of the T2 Protect AD Study,
and we are hopeful that the trial will demonstrate at its
completion that troriluzole ameliorates the symptoms of Alzheimer's
disease."
Troriluzole is an oral, once-daily tablet that modulates
glutamate and is being evaluated as a symptomatic treatment for
mild-to-moderate Alzheimer's disease in the T2 Protect AD Study
(clinicaltrials.gov identifier NCT03605667). The trial is a Phase
2/3, randomized, double-blind, placebo-controlled study 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 University of California 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, "We are encouraged by advancing past the prespecified
futility criteria after the first 100 patients completed six months
of treatment and we look forward to full results upon study
completion. This is an important milestone for our glutamate
development program as troriluzole continues to be studied in four
pivotal Phase 2/3 trials evaluating its efficacy in multiple
neurologic and neuropsychiatric disorders. We are grateful to both
the ADCS and patients participating in our trial to evaluate the
potential efficacy of troriluzole in AD."
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 believe that troriluzole is a promising potential therapy
for people suffering from the devastating impact of Alzheimer's
disease," commented Irfan Qureshi,
MD, Vice President of Neurology at Biohaven. "We are very excited
that the T2 Protect AD Study, which recently completed enrollment,
has now passed the interim futility analysis."
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 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 the societal 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 Alzheimer's disease
(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. There can be no assurance what the
final results of the trials will demonstrate when completed and
whether troriluzole will actually be an effective treatment for
AD. 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, as updated by the Company's
subsequent Quarterly Report on Form 10-Q for the quarter ended
June 30, 2019, filed with the
Securities and Exchange Commission on August 9, 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.