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News
Acadia Pharmaceuticals' experimental drug remlifanserin failed to hit its primary endpoint in a mid-stage trial for Alzheimer's disease psychosis. The 60-mg dose showed greater improvement over placebo, but not enough to meet the goal of reducing hallucinations and delusions after six weeks. Shares dropped ~12% on the news, though Acadia is pressing ahead with two ongoing late-stage studies.
Acadia Pharmaceuticals received disappointing results Thursday: its experimental drug remlifanserin missed the primary endpoint in a mid-stage trial for Alzheimer's disease psychosis (ADP). The drug, tested at 60 mg and 30 mg once-daily doses, failed to show a statistically significant reduction in hallucinations and delusions after six weeks compared to placebo — the study's main goal. Shares fell roughly 12% in premarket trading.
That said, it wasn't all bad news. The 60-mg dose showed a trend of increasing improvement over placebo throughout the six-week period, and remlifanserin achieved statistical significance on a key secondary measure evaluating overall ADP symptom severity. The drug also demonstrated a clean safety profile — no meaningful difference in side effects versus placebo, no adverse effects on movement or cognition, and no deaths reported.
Acadia says it will continue enrolling patients in two ongoing late-stage studies and will drop the 30-mg dose from the program going forward.
By the Numbers:
Why it matters: Alzheimer's disease psychosis is a serious and underserved condition that increases caregiver burden and nursing home placement. A viable treatment could meaningfully improve quality of life for millions — making the ongoing late-stage trials still worth watching, even after this setback.
