Acasti Announces Positive Top-Line Pharmacokinetic Results

Acasti Pharma Inc. ("Acasti" or the "Corporation")

(TSX-V:APO), an emerging biopharmaceutical company, announces top-line results for its pharmacokinetic (PK) trial evaluating the bioavailability and safety of CaPre® on healthy individuals taking single and multiple daily oral doses of the Corporation's new investigational drug candidate composed of a patent-protected highly concentrated novel omega-3 phospholipid for the prevention and treatment of certain cardiometabolic disorders. "The successful completion of the PK study is another important milestone in the clinical testing of CaPre®," stated Andre Godin, Acasti's Interim President and Chief Executive Officer. "The results confirm that CaPre® is bioavailable, safe and well tolerated. The study was conducted under an US Investigational New Drug (IND) application and is an important part of Acasti's clinical development program." Trial Design The PK trial was an open-label, randomized, multiple-dose, single-center, parallel-design study in healthy volunteers. Forty-two male and female individuals, at least 18 years of age, were enrolled into 3 groups of 14 subjects who took 1, 2 or 4 grams of CaPre®, administered once a day 30 minutes after breakfast. The objectives of the study were to determine the pharmacokinetic profile and safety on Day 1 following a single oral dose and Day 14 following multiple oral doses of CaPre® on individuals pursuing a low-fat diet (therapeutic lifestyle changes diet). The effect of a high-fat meal on the bioavailability of CaPre® was also evaluated at Day 15. Blood samples were collected for assessment of EPA and DHA total lipids in plasma to derive the pharmacokinetic parameters. CaPre® Demonstrated Near Dose Proportionality CaPre® pharmacokinetics appear to be approximately dose proportional over the 1 to 4 gram a day dose range. Following a single daily dose, CaPre® reached steady state (EPA and DHA levels plateaued) within 7 days of dosing. Significant Advantage: Bioavailability of CaPre® Not Meaningfully Affected by Fat Content of Meal The bioavailability of CaPre® does not appear to be meaningfully affected by the fat content of the meal consumed prior to dose administration. "The fact that the bioavailability of CaPre® is not significantly reduced when taken with a low fat meal compared to a high fat meal is an important finding, as a low fat diet is part of the management of hypertriglyceridemic patients," highlighted Pierre Lemieux, PhD, Chief Operating Officer of Acasti. CaPre® Well Tolerated with No Safety Concerns CaPre® was found to be safe and well tolerated at all doses tested, with all subjects completing the study. Three adverse events were reported and considered relating to CaPre®, all of which were mild.