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."
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
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.
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.
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.
Dr. Vlad Coric
Chief Executive Officer
SOURCE Biohaven Pharmaceutical Holding Company Ltd.