Biohaven Pharmaceutical, a clinical-stage biopharmaceutical company with a portfolio of innovative candidates targeting neurological diseases, has recently received notification from the independent Data Safety Monitoring Board (DSMB) to continue its T2 Protect AD clinical trial of troriluzole for the treatment of mild to moderate Alzheimer’s disease (AD). This experimental drug modulates glutamate, the dysfunction of which is known to be implicated in AD. The Phase II/III study is a randomised, double-blind and placebo-controlled trial evaluating the efficacy and safety of troriluzole in people with mild to moderate AD. In this trial, which recently completed enrollment, US research participants received oral capsules (280 mg of troriluzole or placebo) once daily for 48 weeks.
The independent DSMB reported that the trial successfully completed its pre-planned interim futility analysis. The experimental drug has passed the futility review based on pre-specified criteria for the interim analysis, which evaluated cognitive function and hippocampal volume. "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", said Dr. Howard Feldman, Principal Investigator of the T2 Protect AD study.
https://www.biohavenpharma.com/investors/news-events/press-releases/12-06-2019
