Biohaven 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 U.S. 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 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 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 percent 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.
"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,” Vlad Coric, M.D., CEO at Biohaven, said. “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.