Acadia drug misses primary endpoint but advances phase 3 plan
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Acadia reported phase 2 Radiant data showing the 60-mg remlifanserin dose produced a 12.6-point decline on a hallucination and delusion assessment versus a 10.4-point decline on placebo, yielding an effect size of 0.26 and a p-value of 0.0603 that missed the primary endpoint. Analysts described the result as a near miss, and Acadia said safety was favorable with no QT prolongation signal, no deaths on drug, and similar adverse event rates versus placebo. A key secondary endpoint favored the drug nominally, 1.3 versus 0.9, and the company will proceed with phase 3 using the 60-mg dose and refined enrollment criteria.
Acadia will advance 60-mg remlifanserin into phase 3.
Context
The Radiant trial compares remlifanserin to placebo for Alzheimer's disease psychosis. Phase 2 produced near-miss efficacy and good safety. The company plans a phase 3 trial with adjusted enrollment criteria.
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