Pimavanserin meets Ph III endpoints in dementia-related psychosis

5 December 2019

Keeping up the recent momentum of positive news on its CNS drug pimavanserin, Acadia Pharmaceuticals (Nasdaq: ACAD) today presented top-line results from its Phase III HARMONY study at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting, December 4 -7, 2019 in San Diego, California, sending the firm’s share up 10% pre-market.

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).

HARMONY was a double-blind, placebo-controlled, relapse prevention study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis. Currently, there is no US Food and Drug Administration-approved drug for the treatment of dementia-related psychosis.

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