September 9, 2019
BIOINVEST NEWS: Acadia (ACAD)
BIOINVEST BREAKING NEWS – Special Update – ACAD — In Perfect HARMONY
This morning, ACAD released excellent data from the Phase III HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for the treatment of dementia-related psychosis. Â The trial nailed 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. 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 will now be stopped early based on pre-specified stopping criteria requiring a one-sided p-value <0.0033 on the study’s primary endpoint. The company is planning to meet with the FDA regarding a supplemental NDA submission in 2020 and the results from the HARMONY study will be submitted for presentation at upcoming medical meetings.
The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is approved by the FDA for the treatment of dementia-related psychosis. Â We believe this study is a major win for ACAD as the company has had to deal with erroneous short reports and a skeptical Wall Street.
The 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 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 in the double-blind period.
ACAD has delivered excellent Phase III pimavanserin data in the very difficult to treat dementia-related psychosis (DRP). Â The drug is proving that it is a pipeline in a pill and an important new tool to treat DRP in addition to its current approval for PDP. Â This data further de-risks ACAD and increases the odds of premium takeout as Big Pharma/Big Bio are always on the prowl for approved drugs that work in multiple diseases. After the recent MDCO and ESPR positive Phase III results, ACAD is one more successful late-stage study from the MTSL portfolio, and we believe more on the way (e.g., MDCO, PCRX, SGMO, , ZYNE).