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Acadia’s Alzheimer’s Psychosis Drug Misses Main Goal of Mid-Stage Study
The 60 mg dose showed a statistical benefit on a secondary measure, and Acadia will continue Phase 3 studies while dropping the 30 mg arm.
On Thursday, Acadia Pharmaceuticals announced its experimental drug remlifanserin missed the primary goal of a mid-stage study testing whether it could reduce hallucinations and delusions in Alzheimer's disease psychosis patients, sending shares down about 11%.
Approximately 30% of patients with Alzheimer's disease experience psychosis involving frequent hallucinations and delusions; these symptoms increase caregiver burden and nursing home placement, yet no therapies are currently approved specifically for this condition.
While the 60-milligram dose showed greater improvement than placebo, it fell short of the primary goal; however, the dose achieved statistical significance on a key secondary endpoint measuring overall symptom severity, with safety profiles remaining similar to placebo.
Acadia will continue enrolling patients in two ongoing late-stage studies while removing the 30-milligram treatment arm from the program; BMO Capital Markets analyst Evan Seigerman noted the secondary success suggests a potential path forward.
Despite the missed primary goal, the company still expects remlifanserin to generate about $4 billion in peak sales potential; Acadia plans to present detailed results at the Clinical Trials on Alzheimer's Disease conference on November 16.