San Diego — Acadia Pharmaceuticals reported topline Phase 2 results from its RADIANT study of remlifanserin for hallucinations and delusions associated with Alzheimer’s disease psychosis, saying the findings support continued Phase 3 development of the 60 mg once-daily dose.
In the study, the 60 mg dose narrowly missed the primary endpoint measuring change in hallucinations and delusions, with a p-value of 0.0603. Patients receiving remlifanserin showed a 12.6-point improvement from baseline compared with a 10.4-point improvement for placebo at week six.
On a key secondary endpoint measuring overall disease severity, the 60 mg dose produced a 1.3-point improvement from baseline compared with 0.9 points for placebo, with a nominal p-value of 0.0077.
Acadia said the treatment effect for the 60 mg dose increased over the six-week treatment period, while the 30 mg dose showed minimal improvement compared with placebo.
Remlifanserin was generally well tolerated across both doses, with rates of adverse events, serious adverse events and treatment discontinuations similar to placebo. The company said there was no signal of QT prolongation and no apparent negative effect on motor symptoms or cognition. No deaths were reported in the remlifanserin treatment groups.
“We are pleased that the Phase 2 RADIANT data support continuation of the Phase 3 ADP program, with new insights helping us to refine the program for future regulatory success,” said Catherine Owen Adams, Chief Executive Officer of Acadia Pharmaceuticals. “These results provide valuable information regarding the efficacy, safety and tolerability of once daily remlifanserin in Alzheimer’s disease psychosis.”
Based on the results, Acadia plans to continue enrolling patients in two ongoing Phase 3 studies while modifying the program to remove the 30 mg dose arm.
Jeffrey Cummings, M.D., Sc.D., Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, said the findings provide encouraging evidence that the 60 mg dose may reduce hallucinations and delusions in patients with Alzheimer’s disease.
Acadia plans to present detailed results from the Phase 2 study at the Clinical Trials on Alzheimer’s Disease conference, scheduled for Nov. 16-19 in Boston.
Remlifanserin is also being evaluated in a separate Phase 2 study for Lewy body dementia psychosis.
