Biohaven Enrolls 1st Patient in Phase 2/3 Trial of Trigriluzole for Mild to Moderate Alzheimer’s
Biohaven Pharmaceuticals has enrolled the first patient in its Phase 2/3 clinical trial investigating the potential of trigriluzole as a treatment for patients with mild to moderate Alzheimer’s disease.
The study, which is currently recruiting, is being conducted in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS) at four clinical sites in the U.S.
Trigriluzole, also known as BHV-4157, is a new compound precursor of riluzole — an approved medication for amyotrophic lateral sclerosis (ALS) — designed to regulate glutamate activity, one of the most abundant and important signaling molecules in the brain.
It has a wide range of pharmacological actions targeting several mechanisms impaired in Alzheimer’s patients. Preclinical studies in animal models and post-mortem human tissue suggest trigriluzole may protect from Alzheimer’s-related pathology and cognitive dysfunction by protecting brain cells and improving their response to glutamate.
“Biohaven is committed to efficiently developing novel therapies for severe neurological diseases so this is an important clinical milestone for the company,” Irfan Qureshi, MD, executive director of neurology at Biohaven, said in a press release. “Based on compelling preclinical research, trigriluzole represents a promising therapeutic option for patients and families suffering from mild-to-moderate Alzheimer’s disease and we look forward to collaborating with the ADCS.”
The randomized, double-blind trial (NCT03605667) is expected to enroll 292 patients with diagnosed Alzheimer’s disease who have Mini-Mental State Examination scores — a test to help diagnose dementia and assess its progression and severity — of 14 to 24, which corresponds with mild to moderate disease.
Patients who have been taking approved therapies such as acetylcholinesterase inhibitors or Namenda (memantine) for a minimum of three months and are willing to continue the treatment during the trial may also be eligible to participate.
Participants will be randomly assigned to receive 280 mg of oral trigriluzole or a placebo, taken once daily at bedtime for 48 weeks. They will also undergo a four-week post-treatment observation period.
The investigators will evaluate the potential of the compound to improve patients’ cognitive function, determined by changes in the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11). The ADAS-Cog 11 evaluates and rates different features of cognitive function such as memory, reasoning, language, and orientation, with scores ranging from zero (best) to 70 (worse).
“We are excited to advance trigriluzole in another late-stage clinical trial that reflects the broad therapeutic potential of trigriluzole in neurologic conditions,” said Vlad Coric, MD, CEO of Biohaven. “The trial, if positive, may contribute to the regulatory package necessary to establish the effectiveness of trigriluzole for the treatment of Alzheimer’s disease.”
Biohaven is also exploring the therapeutic potential of trigriluzole as a treatment for obsessive compulsive disorder (NCT03299166) and spinocerebellar ataxia (NCT02960893).
