Biohaven Pharmaceutical has enrolled the first patient in a Phase ll/lll clinical trial to examine the efficacy and safety of trigriluzole (BHV-4157) for the treatment of patients with mild-to-moderate Alzheimer's disease (AD).
The randomised, double-blind, placebo-controlled trial is being carried out in partnership with Alzheimer's Disease Cooperative Study (ADCS) at various sites across the US.
Around 292 AD patients with mini-mental state examination scores of 14-24 at screening are expected to be enrolled in the trial.
In addition, patients who are on stable doses of the US Food and Drug Administration (FDA) approved AD medications, including acetylcholinesterase inhibitors (AchEI) and/or memantine, for at least three months prior to screening and who are willing to remain on the same regimen during the course of the trial can take part.
The patients are set to be randomised in a 1:1 ratio to receive 280mg of trigriluzole or placebo, taken orally at bedtime, for a period of 48 weeks.
Biohaven Pharmaceutical executive director Irfan Qureshi said: “Biohaven is committed to efficiently developing novel therapies for severe neurological diseases so this is an important clinical milestone for the company.
“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.”
AD, a progressive, fatal neurodegenerative dementia, is estimated to account for 60% to 80% of the dementia cases.
No curable treatment is currently available for AD. However, FDA has approved some medications for symptomatic treatment of the disease.