Acadia advances Alzheimer’s psychosis drug to Phase 3 after trial misses endpoint

Acadia Pharmaceuticals said the Phase 2 portion of its Phase 2/3 Radiant trial of remlifanserin for Alzheimer’s psychosis missed its primary endpoint. At Week 6, the 60-mg dose was linked to a 12.6-point drop on an assessment of hallucinations and delusions, compared with a 10.4-point decline on placebo. The result was a 0.26 effect size, with a p-value of 0.0603.

Acadia said the findings support further development of the 60-mg dose in Phase 3. The company reported similar rates of adverse events, serious adverse events and discontinuations because of side effects in the treatment and placebo groups, with no signal of QT prolongation versus placebo. Acadia is considering changes to Phase 3 enrollment criteria, and applying the proposed criteria to the Phase 2 data raised the effect size to 0.33.