During the quarter, Acasti announced positive results for its randomized, open-label, dose ranging, multi-centre ("COLT") trial, designed to evaluate the safety and efficacy of different daily doses of CaPre ® on patients with mild to severe hypertriglyceridemia. CaPre ® was found to be safe and effective with significant mean triglyceride reductions above 20% after 8 weeks of treatment with both daily doses of 4.0 grams and 2.0 grams. No serious events were reported indicating that CaPre ® is safe and tolerable at all doses tested. The efficacy of CaPre ® at all doses and increased effect with dose escalation suggests that CaPre ® may be titratable, allowing physicians to adjust dosage in order to better manage patients' medical needs. Going forward, the Corporation plans to release full COLT trial results at an international scientific forum.
Acasti's other Phase II study, a randomized, double-blind, placebo-controlled ("TRIFECTA") trial remains on track, with completion continued to be expected for the first half of calendar 2014. On top of this, Acasti also continues to progress with its US strategy to submit an Investigational New Drug (IND) filing to initiate PK and Phase III clinical trials of CaPre ®. The Corporation intends to do this in a two-step process, initially seeking approval to conduct a PK study and subsequently amending it to include phase III studies. "The PK study will set the stage for discussions with the FDA to conduct pivotal phase III studies in the USA," highlighted Dr. Waksal. The PK IND submission is expected to be done in the current quarter ending November 30, 2013, while the amended version requesting approval to conduct Phase III trials should be completed by the end of this fiscal year.
About Acasti Pharma Inc.Acasti is developing a product portfolio of proprietary novel long-chain omega-3 phospholipids. Phospholipids are the major component of cell membranes and are essential for all vital cell processes. They are one of the principal constituents of High Density Lipoprotein (good cholesterol) and, as such, play an important role in modulating cholesterol efflux. Acasti's proprietary novel phospholipids carry and functionalize the polyunsaturated omega-3 fatty acids EPA and DHA, which have been shown to have substantial health benefits and which are stabilized by potent antioxidants. Acasti is focusing initially on treatments for chronic cardiovascular and cardiometabolic conditions within the medical food and prescription drug markets.