Phase III HARMONY study of Nuplazid meets primary endpoint in dementia-related psychosis.- Acadia Pharma

Acadia Pharmaceuticals presented positive top-line results from its Phase III HARMONY study of Nuplazid (pimavanserin) for the treatment of dementia-related psychosis. Pimavanserin 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).

The Phase III 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 Assessment of Positive Symptoms-Hallucinations and Delusions (SAPS-H+D) score improved by 63.0% and 75.2% respectively. Pimavanserin was well-tolerated over the entire 9-month study duration.

Acadia is planning to meet with the FDA in the first half of 2020 regarding a supplemental NDA submission. Data were presented at the 12th Clinical Trials on Alzheimer�s Disease (CTAD) Meeting.