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.
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.
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