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ACADIA Pharmaceuticals Presents Positive Top-line Results from Pivotal Phase 3 HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis at 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting
- Pimavanserin met the primary endpoint in the study, significantly reducing the risk of relapse of psychosis by 2.8 fold (Hazard Ratio (HR)=0.353, one-sided
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- Pimavanserin met the primary endpoint in the study, significantly reducing the risk of relapse of psychosis by 2.8 fold (Hazard Ratio (HR)=0.353, one-sided p=0.0023)\n\n\n- Pimavanserin met the key secondary endpoint in the study, significantly reducing the risk of discontinuation for any reason by 2.2 fold (HR=0.452, one-sided p=0.0024)\n\n\n- Currently, there is no FDA-approved drug for the treatment of dementia-related psychosis\n\n\n- Webcast to be held today at 7:15 p.m. Pacific Time\n\n SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today presented positive top-line results from its Phase 3 HARMONY study at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting, December 4 -7, 2019 in San Diego, California. HARMONY was a double-blind, placebo-controlled, relapse prevention study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis.\n\n\nPimavanserin met the primary endpoint of the study and was stopped at the pre-planned interim analysis by significantly reducing risk of relapse of psychosis by 2.8 fold compared to placebo (HR = 0.353; one-sided p=0.0023). In addition, pimavanserin met the key secondary endpoint by significantly reducing risk of discontinuation for any reason by 2.2 fold (HR = 0.452; one-sided p=0.0024).\n\n\n“The results presented today are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available,” said Jeffrey Cummings, M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “Reducing the risk of relapse of psychotic symptoms by this magnitude is an important and meaningful outcome as these are serious events which could lead to poor patient outcomes and a significant increase in caregiver burden and distress.”\n\n\nThe Phase 3 HARMONY study included a 12-week open-label pimavanserin treatment period prior to the randomization period of the study. In this open-label treatment period, 61.8% of eligible patients met pre-specified criteria for pimavanserin treatment response at both week 8 and week 12 and were subsequently randomized into the double-blind period of the study. For patients in the open-label treatment period, change from baseline to week 8 and week 12 on the Scale for the Ass...