Acadia's Alzheimer's psychosis drug misses main goal of mid-stage study
ACAD•Acadia Pharmaceuticals said its experimental drug remlifanserin missed the main goal of a mid-stage study, although the 60-milligram dose met a key secondary goal. The company will continue enrolling patients in two late-stage studies and remove the 30-milligram treatment arm.
1. Study misses primary goal
Patients taking 60 milligrams of remlifanserin daily showed greater improvement than those on placebo in reducing hallucinations and delusions, but the difference was not enough for the study to meet its main goal. The 30-milligram dose showed little benefit across study measures.
2. Late-stage studies continue
Acadia said it would continue enrolling patients in two ongoing late-stage studies and remove the 30-milligram treatment arm. The company is evaluating modest changes to patient selection criteria after analyses suggested patients with more severe psychosis symptoms may benefit more. It still expects the drug to have about $4 billion in peak sales potential across Alzheimer's disease psychosis and Lewy body dementia psychosis.
3. Safety and company comments
Acadia said rates of side effects, serious side effects and treatment discontinuations were similar to placebo, with no apparent adverse effects on movement or cognitive function and no deaths among treated patients. The company's head of research and development said the phase two study provided information to help design the phase three program.
