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ACADIA Pharmaceuticals Announces Late-Breaking Oral Presentation of the Phase 3 HARMONY Study of Pimavanserin in Dementia-Related Psychosis at the Clinical Trials on Alzheimer’s Disease (CTAD) 2019 Meeting
SAN DIEGO--(BUSINESS WIRE)-- ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the presentation of the results from the Phase 3 HARMONY study
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the presentation of the results from the Phase 3 HARMONY study of pimavanserin in dementia-related psychosis has been accepted for a late-breaking oral communication at the upcoming 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting, December 4-7, 2019 in San Diego, California.\n\n\nLate-Breaking Oral Presentation\n\n\n\nPresentation: LB1\n\n\nAbstract Title: HARMONY Relapse-Prevention Study: Pimavanserin Significantly Prolongs Time to Relapse of Dementia-Related Psychosis\n\n\nPresentation Date: Wednesday, December 4, 2019\n\n\nPresentation Time: 5:45 p.m. Pacific Time\n\n\n\nOn September 9, 2019, ACADIA announced that the Phase 3 HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating an investigational use of pimavanserin for the treatment of dementia-related psychosis, met its primary endpoint. In the study pimavanserin demonstrated a highly statistically significant longer time to relapse of psychosis compared to placebo. Upon the recommendation of the study’s independent data monitoring committee, which met to review the data from the planned interim efficacy analysis, the study was stopped early based on demonstration of efficacy. The pre-specified stopping criteria at the planned interim efficacy analysis required a one-sided p-value less than 0.0033 on the study’s primary endpoint.\n\n\nAbout the HARMONY Study\n\n\nHARMONY is a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of delusions and hallucinations associated with dementia-related psychosis across a broad population of patients with the most common subtypes of dementia including: Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders.\n\n\nThe HARMONY study included a 12-week open-label stabilization period during which patients with dementia-related psychosis were treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg once daily was allowed if clinically justified within the first four weeks. Following the 12-week stabilization period, patients who met pre-specified criteria for treatment response were then randomized into the double-blind period of the study to continue their pimavanse...