NEW HAVEN, Conn., July 22, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (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."
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
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.
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.
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.
Dr. Vlad Coric
Chief Executive Officer
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