Acadia Pharmaceuticals Announces Phase 3 Enabling Topline Results from Phase 2 RADIANT Study of Remlifanserin for the Treatment of Alzheimer’s Disease Psychosis (ADP)
Acadia Pharmaceuticals announced Phase 3-enabling topline results from the Phase 2 RADIANT study of remlifanserin in Alzheimer's disease psychosis. The 60 mg once-daily dose narrowly missed the primary SAPS-H+D endpoint (p=0.0603, effect size 0.26) but achieved nominal significance on the key secondary CGI-S-ADP endpoint (p=0.0077, effect size 0.37), with a placebo-like safety profile and no QT or cognition/motor signal. Acadia will continue its two ongoing Phase 3 studies while amending the program to drop the 30 mg arm, which showed minimal improvement; detailed data will be presented at the CTAD conference November 16-19 in Boston.
Key figures
- Drug Name
- Remlifanserin
- Phase Of Trial
- Phase 2 (Phase 3-enabling)
- Effect size saps h d
- 0.26
- Saps h d 60mg change
- -12.6
- Effect size cgi s adp
- 0.37
- Saps h d placebo change
- -10.4
- Primary endpoint p value
- 0.0603
- Secondary endpoint p value
- 0.0077
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