Acasti Receives Full Data for Phase II TRIFECTA Trial

Loading...
Loading...
Acasti Pharma Inc. ("Acasti" or the "Corporation")
ACST
(TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, 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 (good cholesterol), no deleterious effect on LDL-C (bad cholesterol) and no safety concerns. With full data, Acasti is now able to meet with the US Food and Drug Administration (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, 2015. "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 Chief Operating Officer. "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."
Loading...
Loading...
Market News and Data brought to you by Benzinga APIs
Posted In: NewsFDAPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...