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July 9, 2014
08:08 EDTACSTAcasti Pharma completes Phase II TRIFECTA, Pharmacokinetic trials
Acasti Pharma announces the completion of two trials, the Phase II double-blind, placebo-controlled, or TRIFECTA, study and the Pharmacokinetic trial. The primary objective of the TRIFECTA trial is to evaluate the safety and efficacy of CaPre in reducing triglyceride levels in patients with mild to severe hypertriglyceridemia. Given that the stopping threshold had been met, the data review committee members recommended that there was sufficient evidence of a treatment effect that warranted the termination of the study. The corporation intends to unblind the study and top-line results are expected by the end of September, with full data coming out in the following quarter. Acasti's Pharmacokinetic trial is designed to evaluate blood profiles and bioavailability in healthy human volunteers taking single and multiple doses of Capre. Top-line results are expected to be available by the end of September, with full data coming out in the following quarter.
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March 2, 2015
07:56 EDTACSTAcasti Pharma receives full data for Phase II TRIFECTA trial
Acasti Pharma announces that it has received full data for its Phase II double blind, placebo controlled TRIFECTA trial. The full set of data further confirms and supports the positive Phase II TRIFECTA results announced in September 2014, on the safety and efficacy of CaPre in the treatment of patients with hypertriglyceridemia. As previously announced, the TRIFECTA trial's primary endpoint was met, with patients on 1 gram or 2 grams of CaPre achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, benefits in other key cholesterol markers were announced, including slight increases in HDL-C, no deleterious effect on LDL-C and no safety concerns. With full data, Acasti is now able to meet with the FDA to discuss next steps in the clinical development of CaPre. The meeting is expected to take place in the Corporation's first quarter, ending May 31. "With the encouraging results announced to date, we are well positioned to move forward with our clinical program, including a pivotal Phase III trial for CaPre in patients with severe hypertriglyceridemia," said Pierre Lemieux, PhD, Acasti's COO. "In anticipation that we will eventually receive approval to conduct a Phase III trial, we are ramping up production of CaPre clinical material, using current Good Manufacturing Practices, to ensure a quality product in sufficient quantities is available. This will allow us to avoid any delays due to inventory shortages."

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