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Biohaven’s experimental AD drug fails to meet its co-primary endpoints in Phase II/III study

Tuesday 26 January 2021

On 18 January, Biohaven Pharmaceutical, a clinical-stage biopharmaceutical company with a portfolio of innovative candidates targeting neurological diseases, announced that its Phase II/III clinical trial of troriluzole in Alzheimer’s disease (AD) has missed its co-primary endpoints. This experimental drug modulates glutamate, the dysfunction of which is known to be implicated in AD. In this randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of troriluzole, 350 US research participants with mild to moderate AD received oral capsules (280 mg of troriluzole or placebo) once daily for 48 weeks.

A focused analysis showed that participants taking the drug, troriluzole, showed no statistically significant cognitive improvement compared to a placebo after 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). Troriluzole also did not differentiate from placebo on the key secondary measure of hippocampal volume assessed by magnetic resonance imaging (MRI). Top-line results showed that troriluzole was relatively well tolerated and demonstrated a safety profile consistent with previous studies of troriluzole.

The company is continuing to analyse the data, including additional secondary and exploratory efficacy analyses and biomarker data. These results are expected in the coming months and will be presented at an upcoming scientific meeting.