CAPRE BRIDGING STUDY
Acasti’s open-label, randomized, four-way, cross-over, bioavailability study (the Bridging Study) compared omega-3 (EPA and DHA) blood levels achieved after taking CaPre as a single dose of 4 grams in fasting and fed (high fat meal) states, with those after taking a single dose of the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers. The study met its primary objective by demonstrating 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 are expected to support the basis for claiming a comparable safety profile of the two products.
Among subjects in the fasting state, CaPre demonstrated better bioavailability than LOVAZA, as measured by significantly higher blood levels of EPA and DHA. In addition, based on the results obtained in another pharmacokinetic study (CAP13-101), the bioavailability of CaPre is not meaningfully affected by the fat content of a meal consumed prior to drug administration.
Acasti believes this could represent a significant clinical and marketing advantage over LOVAZA and feature of CaPre since the administration with a low-fat meal represents a more appropriate regimen for patients with hypertriglyceridemia who follow a physician-recommended, restricted diet.