Acasti Pharma Reports Positive Bridging Study Data

Acasti Pharma (NASDAQ:ACST) today announced that its drug candidate CaPre® (omega-3 phospholipid) has met objectives in a bridging study. This will further Acasti’s plan to secure FDA approval through the 505(b)(2) regulatory pathway. CaPre will treat severe hypertriglyceridemia.
As quoted in the press release:

Acasti’s open-label, randomized, four-way, cross-over, bioavailability study compared CaPre given as a single dose of 4 grams in fasting and fed states with the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers. The study met its primary objective and demonstrated that the levels of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) following administration of CaPre did not exceed the levels following administration of LOVAZA in subjects who were fed a high-fat meal. These results support the basis for claiming a comparable safety profile of the two products.

According to CEO Jan D’Alvise:

“We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre. With this momentum, we look forward to working with the FDA to confirm the pathway and optimize the design of our Phase 3 program, which will seek to demonstrate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia.”

Read the full press release here.