Biohaven Pharmaceutical Holding Company Ltd, a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, announced its clinical trial collaboration with the Alzheimer's Disease Cooperative Study (ADCS).

The ADCS is a leading Alzheimer's disease (AD) clinical trials research consortium that receives major support from the US National Institute on Aging (NIA), a part of the US National Institutes of Health. The ADCS was developed to promote the discovery, development, and testing of new drugs for the treatment of AD. The ADCS includes a coordinating center housed at the University of California San Diego School of Medicine and a robust network of clinical research sites located at major academic medical centers and private clinics specializing in AD care and research throughout the United States and Canada. The ADCS has successfully completed the largest number of clinical trials in the AD field while also developing some of the important instruments for use within clinical trials. The ADCS has been undertaking the development efforts for this study over the last six months in partnership with Biohaven.

Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for up to 65 per cent of dementias. According to the Alzheimer's Association, there were approximately 5.4 million Americans with AD in 2016, and that number is expected to escalate rapidly in the coming years as the population ages. Mounting observations in multiple preclinical models and post-mortem human AD studies suggest that glutamate dysfunction plays a role in the pathophysiology of the disease and that the active metabolite of trigriluzole may protect from AD-related pathology and cognitive dysfunction.

Vlad Coric, M.D., CEO at Biohaven, commented, "We are excited to be working with the ADCS to evaluate trigriluzole in patients with AD and attempt to alleviate suffering from this devastating disease. We will continue to apply our innovative neuroscience expertise along with the leading external partners to attempt to help patients who currently suffer without safe and effective treatments."

Trigriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple diseases that involve glutamate dysfunction. As part of this collaboration, Biohaven will fund a randomized, double-blind, placebo-controlled, phase 2 clinical trial to evaluate the efficacy and safety of trigriluzole in patients with mild-to-moderate AD.

Howard Feldman, MD, FRCP, director of the ADCS and professor of neurosciences at UC San Diego School of Medicine added, "We are excited to be developing an innovative clinical trial with Biohaven with a trial design that will allow us to use incoming trial data to inform our progress in advancing this research most efficiently. The preclinical evidence for the active metabolite of trigriluzole to modulate glutamate and confer neuroprotective effects in AD patients appears to be compelling, and the new formulation of trigriluzole may improve its pharmacological properties and potential for efficacy in AD."