Local Researchers Part of National Study Evaluating if New Prodrug Can Slow Progression of Alzheimer's Disease

Great Lakes Clinical Trials has screened its first participant in a new, national Alzheimer’s disease (AD) clinical research study evaluating the potential benefits of an investigational medicine for people with mild-to-moderate AD.

The Phase 2 study, called T2 Protect AD, is evaluating the investigational drug troriluzole (BHV-4157), which may have the potential to protect against, slow down, and eventually improve memory and thinking problems that increase as Alzheimer’s disease progresses. Troriluzole is a drug that modulates glutamate, protecting against neuron loss. Glutamate problems in the brain can lead to brain cell dysfunction and disease, including Alzheimer’s disease.

Troriluzole is a prodrug of riluzole, a drug first approved by the Federal Drug Administration in 1995 to slightly slow disease progression in patients with Amyotrophic Lateral Sclerosis (ALS).

“We are hoping this drug truly makes a difference in slowing progression of this illness,” said Dr. Jeffrey Ross, Medical Director at Great Lakes Clinical Trials. “It’s a unique compound that takes a different approach than most recent drugs. Riluzole has shown efficacy in ALS patients, and the prodrug now offers the possibility of helping those with Alzheimer’s, and with fewer side effects.”

A prodrug is an inactive medication that changes into a drug after ingestion. When a person takes troriluzole, the body converts it into the active drug riluzole. This means the prodrug troriluzole can be taken once a day, while riluzole is administered twice a day. Unlike riluzole, patients do not need to fast before and after taking troriluzole, and troriluzole has potential for better safety and tolerability than riluzole.

Great Lakes Clinical Trials is one of more than 30 sites in the U.S. participating in the T2 Protect AD study. The study is sponsored by New Haven-based Biohaven Pharmaceutical Holding Company Ltd., and is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), a large clinical research consortium, based at the University of California, San Diego.

The T2 Protect AD trial comes at a time when Alzheimer’s research is focused on earlier stages of the disease and there are not as many clinical trials for people already diagnosed with Alzheimer’s. “Simply put, we need to identify more and better treatments for the millions of people already diagnosed with Alzheimer’s disease and the T2 Protect Study is designed for that population” said Ross.

Clinicians at Great Lakes Clinical Trials are now seeking eligible participants for the T2 Protect AD study. To enroll in T2 Protect AD, participants must be between age 50 and 85, diagnosed with mild-to-moderate Alzheimer’s disease, and already being treated with Alzheimer’s medications for at least three months. Participants must have a study partner who has regular contact with the clinical trial candidate and is able to attend study visits.

For more information about participating in the T2 Protect AD study at Great Lakes Clinical Trials, call 773-275-3500, email Amber Holst at aholst@greatlakesclinicaltrials.com or visit http://www.greatlakesclinicaltrials.com/t2protect

The T2 Protect AD study is happening at more than 40 clinical sites across the country, including Great Lakes Clinical Trials, seeking to slow or stop memory and thinking problems in those with mild to moderate Alzheimer's disease.

About Alzheimer’s disease

An estimated 5.7 million people in the U.S. suffer from mild-to-moderate AD, with those numbers expected to triple by 2050 without prevention or cure. Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for 60 - 80 percent of dementia cases. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as troriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.

About Biohaven

Biohaven Pharmaceutical Holding Company Ltd. is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven 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 and glutamate modulation platforms. The Company's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is at www.biohavenpharma.com

About Alzheimer’s Disease Cooperative Study

The Alzheimer’s Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a major initiative for Alzheimer’s disease (AD) clinical studies, addressing treatments for both cognitive and behavioral symptoms. The ADCS is part of the NIA Division of Neuroscience’s effort to facilitate the discovery, development and testing of new drugs for the treatment of AD. www.adcs.org