Acasti Pharma, Inc (ACST)

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Acasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package
8:08 am ET June 19, 2020 (Globe Newswire) Print

Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST - TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre(R) (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the FDA has provided Acasti with a written response to its Type C Meeting request and briefing package.

The FDA confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat (ITT) population as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Consistent with the Company's prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission.

Acasti and its expert advisors are carefully considering the FDA's comments on the TRILOGY 1 data and will conduct further post-hoc analysis based on their feedback. Concurrent with reporting the Company's year-end financial results and investor conference call on June 29, 2020, the Company will provide more information on TRILOGY 1 post-hoc analyses conducted to date in a detailed update to shareholders along with the plan for the unblinding and reporting of the TRILOGY 2 results.

Conference Call

The Company will host a conference call at 1:00 PM Eastern Time on Monday, June 29, 2020 to discuss the Company's financial results for the year ended March 31, 2020, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre.