Acasti Pharma Says Phase 3 TRILOGY 2 Study Did Not Meet Primary Endpoint - Quick Facts

Biopharmaceutical company Acasti Pharma Inc. (ACST) announced Monday top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The study did not meet its primary endpoint.

The Company reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks (the Primary Endpoint), as compared to 27.5% in TRILOGY 1.

The unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a "p" value of 0.19, which was not statistically significant.

As a result, the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.

CaPre was well tolerated in TRILOGY 2, with a safety profile similar to placebo, and consistent with the Company's previously conducted Phase 2 and 3 studies.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT