Acadia's Alzheimer's Drug Faces Setback in Study

Acadia Pharmaceuticals reported on Thursday that its experimental drug, remlifanserin, did not meet the main objective in a mid-stage clinical trial aimed at treating psychosis associated with Alzheimer's disease. Patients receiving a 60-milligram daily dose exhibited greater improvement in reducing hallucinations and delusions compared to a placebo, yet the difference did not achieve statistical significance for the study's primary goal.

A lower 30-milligram dose demonstrated minimal benefit across various measures. However, the higher dose did achieve a key secondary goal, indicating an overall reduction in the severity of Alzheimer's disease psychosis symptoms. Acadia plans to continue enrolling participants in two ongoing late-stage studies, discontinuing the 30-milligram arm.

The company anticipates remlifanserin could achieve approximately US$4 billion in peak sales, encompassing both Alzheimer's disease psychosis and Lewy body dementia psychosis. Adjustments to patient selection criteria are being considered, following analyses suggesting that individuals with more severe psychosis symptoms might benefit more from the treatment.

Adverse events, serious side effects, and treatment discontinuations were comparable to placebo. Importantly, no adverse effects on motor or cognitive functions were observed, and no deaths occurred among patients receiving the drug. Alzheimer's disease psychosis affects approximately 30% of individuals with Alzheimer's, leading to increased caregiver burden and healthcare needs.