Biohaven Pharmaceutical (Biohaven) has initiated a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator, in patients suffering with mild-to-moderate Alzheimer’s disease (AD).
The trial comes after Biohaven’s filing of an investigational new drug application (IND) for trigriluzole in AD, and receipt of authorisation from FDA to proceed with clinical investigation.
The company is undertaking the trial in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS), and the first AD patient is expected to enrol in the coming weeks.
Biohaven CEO Vlad Coric said: “We are very pleased with the FDA’s acceptance of the IND for trigriluzole for the treatment of Alzheimer’s disease. We have designed our Phase 2/3 trial to serve as a well-controlled trial that, if positive, may contribute to establishing the effectiveness of trigriluzole for the treatment of Alzheimer’s disease.”
The Phase 2/3 clinical trial is a randomised, double-blind, placebo-controlled trial which will evaluate the efficacy and safety of trigriluzole in patients diagnosed with AD with mild-to-moderate condition.
Patients who have been taking stable doses of FDA-approved AD medications such as acetylcholinesterase inhibitors (AchEI) and memantine for at least three months prior to screening can participate in the trial.
Around 292 patients will be randomised on a 1:1 basis to receive 280mg of trigriluzole or placebo, taken orally at bedtime.
The treatment will be conducted for 48 weeks.
Alzheimer’s disease is a progressive, fatal neurodegenerative dementia that accounts for 60% to 80% of dementia cases. Alzheimer’s disease currently has no cure. There are FDA-approved medications for symptomatic treatment of AD; however, these offer limited clinical benefits.
A third-generation prodrug and new chemical entity that modulates glutamate, which is the most abundant excitatory neurotransmitter in the human body, known as trigriluzole has several pharmacological actions, including interactions with several kinds of ion channels, cellular signalling mechanisms and facilitation of glutamate reuptake.