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Acasti Pharma shares nudge higher as it files meeting request with the US Food and Drug Administration

The company is developing a krill-oil derived prescription drug called CaPre to treat hypertriglyceridemia

Acasti Pharma Inc -
The firm has carried out two Phase III trials on the drug candidate — TRILOGY 1 and TRILOGY 2

Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) saw shares tick up Wednesday as it told investors it had filed a meeting request with the Food and Drug Administration (FDA) and expects this to take place in the second half of June.

The company is developing a krill-oil derived prescription drug called CaPre to treat hypertriglyceridemia (high levels of triglycerides in the blood), which is known to contribute to heart disease.

READ: Acasti Pharma making 'steady progress' on CaPre trials, says CEO

The firm carried out two Phase III trials on the drug — TRILOGY 1 and TRILOGY 2.

As previously reported, the firm identified some "unexpected and inconsistent findings" in the TRILOGY 1 trial that it believes may have negatively contributed to the overall topline results.

Following that, Acasti announced an audit and analysis of the study data.

"The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results," Acasti said in a statement.

It 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 agree on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of a New Drug application (NDA) filing. 

Acasti remains blinded to the TRILOGY2 results and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees.

"We are pleased to have completed the TRILOGY 1 clinical site and central lab audits as planned, including additional post-hoc analyses, and to have submitted our meeting request to the FDA on schedule," said Jan D’Alvise, president and CEO of Acasti Pharma.

"We believe the FDA meeting will provide essential guidance as we prepare to unblind and conduct the topline analysis of the TRILOGY 2 data. We look forward to meeting with the FDA and providing further updates as they unfold."

Shares in Toronto ticked up 1.89% to stand at C$0.54 each.

Contact the author at [email protected]

Quick facts: Acasti Pharma Inc

Price: 1.02 CAD

TSX-V:ACST
Market: TSX-V
Market Cap: $92.01 m
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Full interview: Acasti has 'put its finger on something very interesting' in...

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

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