Extensive market research by Acasti Pharma Inc (NASDAQ:ACST) on cardiovascular disease and associated risks has outlined an urgent need for effective, safe, and well-absorbing omega-3 therapeutics.
Over the years, the biopharmaceutical innovator has put extra effort and resources in the research of omega-3 fatty acids. However, the company has suffered a setback with lead product candidate CaPre® (omega-3 phospholipid).
In its Phase 3 TRILOGY 2 study, the candidate was market as a potential treatment for severe hypertriglyceridemia (sHTG). The study evaluated its efficacy, safety, and tolerability enrolled 278 patients with severe hypertriglyceridemia. However, the company says that it failed to accomplish statistical significance for the primary endpoint.
From the results, patients receiving CaPre had a 30.4% median reduction in triglyceride levels compared to 30.5% in TRILOGY 1. On the other hand, those receiving placebo at 12 weeks had a 17.9% median reduction in triglyceride levels compared to 27.5% in TRILOGY 1.
The company will not file a New Drug Application (NDA) for its CaPre
The Trilogy 2 study outcome was very disappointing, as reported by the CEO of Acasti, Jan D’Alvise. The company was very hopeful about obtaining positive outcomes from TRILOGY 2, given the data received from TRILOGY 1. Nonetheless, this was not the case.
That said Acasti will not be filing a New Drug Application (NDA) with the FDA even though D’Alvise was quick to say, “We are very disappointed in the outcome of the Trilogy 2 study. Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same…’’
Maximizing on the Value of the CaPre® Asset
The intention is to use CaPre as therapy while incorporating positive lifestyle changes such as the proper diet. It can be administered alone or together with other treatment regimens such as statins.
With that in mind, Acasti says it is not losing hope on it despite the inadequate data. The company will be reviewing the full dataset to complete the full data analyses. It will also evaluate other strategic options, which will maximize the value of CaPre® fully.
