Acadia's Alzheimer's psychosis drug misses key mid-stage study goal

• The 60-mg once-daily dose showed greater improvement than placebo but fell short of statistical significance on the primary endpoint, though improvement increased throughout the six-week period
• The drug achieved statistical significance on a key secondary measure evaluating overall severity of Alzheimer's disease psychosis symptoms
• Safety profile was favorable with side effect rates similar to placebo, no apparent adverse effects on movement or cognitive function, and no deaths reported among patients receiving the drug

Summary

Acadia Pharmaceuticals announced Thursday that its experimental Alzheimer's psychosis drug, remlifanserin, failed to meet the primary endpoint in a mid-stage clinical trial. The study aimed to reduce hallucinations and delusions in patients with Alzheimer's disease psychosis, which affects approximately 30% of Alzheimer's patients.

Key Trial Results:

• The 60-mg once-daily dose showed greater improvement versus placebo, but the difference was insufficient to meet the main six-week efficacy goal
• The 30-mg dose demonstrated minimal improvement across study measures
• The drug did achieve statistical significance on a key secondary endpoint measuring overall severity of Alzheimer's disease psychosis symptoms
• Improvement trends increased throughout the six-week treatment period for the 60-mg dose

Safety Profile:

• Side effects, serious adverse events, and treatment discontinuation rates were comparable to placebo
• No adverse effects on movement or cognitive function reported
• No deaths among patients receiving the drug

Next Steps:

Acadia will continue enrolling patients in two ongoing late-stage studies for remlifanserin in Alzheimer's disease psychosis, but will discontinue testing the 30-mg dose in the program.

Market Context:

Alzheimer's disease psychosis represents a significant unmet medical need, increasing caregiver burden and nursing home requirements. While the mid-stage miss is a setback, the positive safety profile and secondary endpoint achievement suggest Acadia remains committed to advancing the treatment through late-stage development.