Biohaven announced it initiated a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator, in patients with mild-to-moderate Alzheimer's disease (AD). The initiation of this trial follows Biohaven's filing of an investigational new drug application (IND) for trigriluzole in AD and receipt from FDA of authorization to proceed with clinical investigation in this indication. The trial is being conducted in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), as previously announced, and the first AD patient is expected to enroll in the coming weeks.
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"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," Vlad Coric, M.D., CEO of Biohaven, said.
Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for 60 - 80 percent of dementia cases. Alzheimer's disease currently has no cure. 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 trigriluzole, 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.
The Phase 2/3 clinical trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening). Patients who have been taking stable doses of FDA-approved AD medications (acetylcholinesterase inhibitors (AchEI) and/or memantine) for a minimum of three months prior to screening and who are willing to remain on the same regimen for the duration of the trial may be eligible to participate. Approximately 292 patients will be randomized on a 1:1 basis to receive 280 mg of trigriluzole or placebo, taken orally at bedtime. Duration of treatment will be 48 weeks.