Acadia to Advance Alzheimer's Drug to Phase 3 on Mixed Phase 2 Trial Results

Acadia Pharmaceuticals announced topline results from its Phase 2 RADIANT study of remlifanserin for Alzheimer's disease psychosis (ADP). The 60 mg dose narrowly missed its primary endpoint but achieved statistical significance on a key secondary endpoint. Based on these findings and a favorable safety profile, the company will continue its two ongoing Phase 3 studies with an amended protocol.

Key Details

• Primary Endpoint: The 60 mg dose did not achieve statistical significance on the primary endpoint (SAPS-H+D), showing a change of -12.6 vs. -10.4 for placebo (p=0.0603).
• Secondary Endpoint: The drug achieved statistical significance on the key secondary endpoint (CGI-S-ADP), with a change of -1.3 vs. -0.9 for placebo (p=0.0077).
• Strategic Update: Acadia plans to continue its Phase 3 program for remlifanserin in ADP and will amend the protocol to remove the 30 mg dose, which showed minimal improvement.
• Safety Profile: Remlifanserin demonstrated a favorable safety profile, with adverse event rates similar to placebo and no negative impact on motor symptoms or cognition.