"We are pleased with the progress of our clinical efforts. Most notably, we are very satisfied with the significant impact on triglyceride even in this hard to treat population of patients in the lower strata of hypertriglyceridemia. Achieving statistical significance with such a low number of patients and only after a short eight-week treatment period definitely encourages us to push our strategy forward towards US clinical studies and validation during the upcoming year" said Harlan Waksal, M.D., Executive Vice-President, Business and Scientific affairs. "The Management's enthusiasm remains strong. We are moving forward to finalize plans for the filing of a US IND for Phase III clinical study in 2013" Dr. Waksal concluded.
"This snapshot of clinical data has given us a first look at the safety and clinical efficacy of this very interesting drug candidate. Even within a small cohort, CaPre® has demonstrated its ability to be a valuable alternative in the control of triglycerides. This early look at data is in line with our expectation of the safety and clinical promise of this patented novel omega-3 entity" stated Dr. Jean Davignon, chairman of the review committee and Emeritus Researcher, Clinical Research Institute of Montreal (IRCM). "The lipidologists community is markedly interested in lipid residual risk reduction in the post-statin era and is always looking for effective drugs" he added.
Acasti Pharma 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 Pharma'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 Pharma is focusing initially on treatments for chronic cardiovascular and cardiometabolic conditions within the over-the-counter, medical food and prescription drug markets.