FDA response expected on or before June 30, 2020
Acasti also received notice of issuance of a Composition of Matter Patent in Hong Kong
LAVAL, Quebec, April 30, 2020 (GLOBE NEWSWIRE) -- 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® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it submitted its briefing package on April 29, 2020 to the Food and Drug Administration (FDA) for review. The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020.
As previously reported, Acasti filed its meeting request at the end of March, and this briefing package is now intended to provide the FDA with a review of the relevant TRILOGY 1 data and audit findings, with the objective to gain alignment on the interpretation of the TRILOGY 1 results and implications for TRILOGY 2. The Company will also seek the FDA’s input on Acasti’s proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and hopefully reach agreement on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 to support an NDA filing. Acasti continues to remain blinded to the TRILOGY 2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees.
Jan D’Alvise, President and CEO of Acasti Pharma, commented, “We have submitted our briefing package to the FDA for their review, and are now awaiting their formal response. We remain optimistic that we may still have a viable path toward filing an NDA. We look forward to the FDA’s feedback on our briefing package, and expect that they will provide valuable guidance on the next steps to be taken towards the unblinding of TRILOGY 2. We will provide more information about our TRILOGY 1 findings, and the FDA’s response to our briefing package and our questions after we get it.”
Acasti also announced today that it has received notice of issuance of a composition of matter patent to be awarded by the Intellectual Property Office in Hong Kong. This new patent grants claims for any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.