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Acasti Pharma hopeful of path towards New Drug Application for CaPre as it submits TRILOGY 1 package

Further analysis took place after topline results from the Phase 3 TRILOGY 1 trial for CaPre did not reach statistical significance

Acasti Pharma Inc -
"We have submitted our briefing package to the FDA for their review, and are now awaiting their formal response," said Jan D’Alvise, the CEO of Acasti Pharma

Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) has updated on the progress of the development of its flagship drug candidate CaPre, saying it submitted its New Drug Application briefing package on April 29 to the US Food and Drug Administration (FDA) for review.

In January this year, the biotech firm reported that further analysis was underway after topline results from its Phase 3 TRILOGY 1 trial for CaPre did not reach statistical significance due to an unusually large placebo effect.

READ: Acasti Pharma shares lifted as it further bolsters its intellectual property portfolio

Acasti filed its FDA meeting request at the end of March, and this briefing package is now intended to provide the regulator with a review of the relevant TRILOGY 1 data and audit findings, in a bid to "gain alignment on the interpretation of the TRILOGY 1 results and implications for TRILOGY 2", the company said in a statement.

TRILOGY 2 was also a Phase 3 study and was carried out in sites in the US, Mexico and Canada.

Jan D’Alvise, the CEO of Acasti Pharma said in the statement: "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."

The company is seeking the FDA’s input on proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP).

Acasti also revealed in Thursday's statement that it has received a 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, Acasti said.

CaPre is a krill-oil derived prescription drug, aimed at treating hypertriglyceridemia, or high levels of triglycerides in the blood, which is known to contribute to heart disease.

Shares advanced over 6% in early Toronto deals to stand at C$0.87 each.

Contact the author at giles@proactiveinvestors.com

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TSX-V:ACST
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Acasti Pharma Inc (NASDAQ:ACST)(CVE:ACST) COO Pierre Lemieux tells Proactive the last patient completed their final visit in its TRILOGY 1 trial of lead drug CaPre, which treats severe hypertriglyceridemia. Lemieux says the Quebec-based company is on its way to reporting results by the end of...

on 26/11/19

2 min read