BioHaven’s Troriluzole Fails Co-Primary Endpoints in Phase 2 Trial for Mild-to-Moderate Alzheimer’s Disease

BioHaven’s Troriluzole Fails Co-Primary Endpoints in Phase 2 Trial for Mild-to-Moderate Alzheimer's Disease

BioHaven Pharmaceuticals announced the outcome from a focused analysis of the topline co-primary and key secondary data from its Phase 2/3 clinical trial of troriluzole as a symptomatic treatment in mild-to-moderate Alzheimer's disease (AD). Additional secondary and exploratory efficacy analyses and biomarker data including neurofilament light chain (NfL), neurogranin, tau and amyloid are still pending and expected in the coming months.

The randomized, double blind, placebo-controlled trial enrolled 350 patients with mild to moderate AD. The patients received titrated doses of BHV-4157 to 280 mg, or placebo, taken orally once daily for 48 weeks. Troriluzole did not statistically differentiate from placebo at 48 weeks on the study's prespecified co-primary endpoints on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) in study participants with mild-to-moderate AD. Troriluzole also did not differentiate from placebo on the key secondary measure of hippocampal volume assessed by magnetic resonance imaging (MRI) in the overall population.

A subgroup analysis consisting ...

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