Acadia Pharmaceuticals announced the phase 3 HARMONY trial, evaluating pimavanserin for the treatment of dementia-related psychosis, met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis. Based on this data, the trial has been stopped early and Acadia plans to initiate discussions with the FDA regarding a regulatory pathway.
HARMONY 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.
The study included a 12-week open-label stabilization period during which patients 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 pimavanserin dose (34 mg or 20 mg per day) or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. The primary endpoint in the study was time to relapse (significant worsening of dementia-related psychosis after prior stabilization) in the double-blind period.
Results from the HARMONY study will be submitted for presentation at upcoming medical meetings. Acadia is planning to meet with the FDA regarding a supplemental NDA submission in 2020.
The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis.
About Dementia-Related Psychosis
Around 8 million people in the United States are living with dementia and studies suggest that approximately 30% of dementia patients, or 2.4 million people, have psychosis, commonly consisting of delusions and hallucinations. Dementia-related psychosis includes psychosis in Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with severe or persistent psychosis in patients with dementia such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality.
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders.
Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. FDA in April 2016 under the trade name Nuplazid.Source: Acadia Pharmaceuticals