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acasti pharma inc (APO) Details

Acasti Pharma Inc., a biopharmaceutical company, is engaged in the research, development, and commercialization of therapies for abnormalities in blood lipids, and the treatment and prevention of various cardiometabolic disorders in Canada and the United States. The company offers Onemia, a medical food that is used in the dietary management of illnesses associated with omega-3 phospholipids deficiency related to cardiometabolic disorders. Its product development pipeline includes CaPre, a drug product candidate that is in Phase II clinical trials for the prevention and treatment of cardiometabolic disorders, including hypertriglyceridemia. The company was incorporated in 2002 and is headquartered in Laval, Canada. Acasti Pharma Inc. is a subsidiary of Neptune Technologies & Bioressources Inc.

Founded in 2002

acasti pharma inc (APO) Top Compensated Officers

Chief Operating Officer
Total Annual Compensation: C$170.3K
Chief Global Strategic Officer
Total Annual Compensation: C$56.0K
Compensation as of Fiscal Year 2014.

acasti pharma inc (APO) Key Developments

Acasti Pharma Inc. Reports Earnings Results for the Second Quarter and Six Months Ended August 31, 2014; Announces Resignation of Dr. Harlan W. Waksal, M.D. as Executive Vice-President, Business & Scientific Affairs

Acasti Pharma Inc. reported earnings results for the second quarter and six months ended August 31, 2014. For the quarter, the company reported revenues of $8,000 versus $266,000 for the quarter ended August 31, 2013. Adjusted EBITDA was negative of $2,449,000 versus negative of $1,763,000 in the prior year. Net loss was $3,712,000 versus a net loss of $3,238,000 in the prior year. The decrease in adjusted EBITDA was attributable to higher R&D expenses, along with increased general and administrative costs, largely associated with salaries and benefits. The higher net loss is due to the aforementioned factors along with a quarterly increase in the fair value of Acasti's derivative warrant liability arising from its 2013 public offering. For the six months, the company reported revenues of revenues of $64,000 versus $273,000 for the corresponding period ended August 31, 2013. Adjusted EBITDA was negative of $4,144,000 versus negative $3,033,000 in the prior year. Net loss was $2,356,000 versus a net loss of $5,203,000 in the prior year. The six-month year-over-year variances are mainly attributable to the factors listed above for the three-months ended August 31, 2014. As well, the lower net loss over the prior year is due to a year-to-date decrease in the fair value of Acasti's derivative warrant liability. The company also announced that Dr. Harlan W. Waksal, M.D. has stepped down as Executive Vice-President, Business & Scientific Affairs, following his recent appointment as President and CEO of Kadmon Corporation. He remains a Director on Acasti's Board.

Acasti Pharma Inc. Announces Top-Line Results for its pharmacokinetic (PK) Trial

Acasti Pharma Inc. announced 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 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 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.

Acasti Pharma Inc. Reports Successful CaPre Phase II TRIFECTA Results Proving Statistically Significant Improvements in Triglycerides & Non-HDL-C

Acasti Pharma Inc. announced successful top-line results for its Phase II double blind, placebo controlled trial (TRIFECTA) assessing the safety and efficacy of CaPre(R) for the treatment of patients with hypertriglyceridemia. CaPre(R), Acasti's investigational new drug candidate, is composed of a patent-protected highly concentrated novel omega-3 phospholipid for the prevention and treatment of certain cardiometabolic disorders. Trial Design: TRIFECTA was a randomized, placebo-controlled, double-blind, dose-ranging trial designed to evaluate the safety and efficacy of CaPre(R) in reducing triglyceride levels in patients with mild-to-severe hypertriglyceridemia, using daily doses of 1 gram or 2 grams of CaPre(R) or placebo over a 12-week period. Placebo consisted of microcrystalline cellulose, a well-known inert substance not absorbed into the bloodstream. Demographic and baseline characteristics of the patient population were balanced. A total of 387 patients were randomized and 365 patients completed the 12-week study, in line with the targeted number of evaluable patients. From this patient population, approximately 90% had mild to moderate hypertriglyceridemia with baseline triglycerides between 200 and 499 mg/dL (2.28 to 5.69 mmol/L). The remainder had very high baseline triglycerides between 500 and 877 mg/dL (> 5.7 and < 10 mmol/L). Approximately 30% of patients were on lipid lowering medications, such as statins, and approximately 10% were diabetic. A Statistically Significant Reduction in Triglycerides: CaPre(R) successfully met the trial's primary endpoint achieving a statistically significant (p < 0.001) mean placebo-adjusted decrease in triglycerides from baseline to week-12, with reductions of 36.4% for 1 gram and 38.6% for 2 grams. Benefits in Other Key Cholesterol Markers: Along with material triglyceride reductions, all key secondary endpoints were met. This is a notable achievement as the trial was not designed to show a statistical significance on any other lipid than triglycerides. Nevertheless, there was a statistically significant decrease in non-HDL-C versus placebo (p=0.038), with the 2 gram per day CaPre(R) group decreasing by 5.3% from baseline versus placebo over the 12-week period. Non-HDL is considered the most accurate risk marker for cardiovascular disease. CaPre(R) was also shown to have a slight increase in HDL-C (good cholesterol) at both the 1 gram and 2 gram levels and decrease in LDL-C (bad cholesterol) at 2 grams. As well, there was a clinically meaningful mean placebo-adjusted reduction in VLDL-C of 10.9% and 13.5% at 1 gram and 2 gram daily doses of CaPre(R), respectively. VLDL-C is considered a highly significant predictor of coronary artery disease. Finally, a statistically significant dose response increase in the Omega-3 Index for patients on 1 gram and 2 grams of CaPre(R) versus placebo was noted. The Omega-3 Index reflects the percentage of EPA and DHA in red blood cell fatty acids. The risk of cardiovascular disease is considered to be lower as the Omega-3 Index increases. CaPre(R) Well Tolerated with No Safety Concern: CaPre(R) was found to be safe and well tolerated at all doses tested, with no serious adverse events that were considered treatment related. Out of 387 randomized patients, a total of 7 (1.8%) were discontinued as a result of adverse events, three were on placebo, two were on 1 gram of CaPre(R) and two were on 2 grams of CaPre(R). The predominant incidence was gastrointestinal related, with no difference between CaPre(R) and placebo. The safety profiles of patients on CaPre(R) and placebo were similar.


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