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Acasti Pharma Inc., a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, announced that it has received a Notice of Allowance for an additional composition of matter and method of use patent from the US Patent and Trademark Office (USPTO), the 4th patent to be awarded in the U.S., and a Notice of Allowance for a composition of matter and method of use patent awarded by the Mexican Patent Office, the 3rd patent to be awarded in Mexico. These new patents broaden the Company’s existing claims to include any composition containing EPA and DHA where at least 50% of the composition consists of phospholipids. These new patents further strengthen the intellectual property position of CaPre. In addition, Acasti also received a favorable decision issued by the Japan Patent Office following an opposition proceeding filed by a third party against its divisional application, confirming its validity. This decision resulted in the allowance of Acasti’s second major patent in Japan.
Acasti’s prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either “free” or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. In two Phase 2 studies, CaPre achieved a statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients across the dyslipidemia spectrum from patients with mild to moderate hypertriglyceridemia (patients with TG blood levels between 200mg/dl and 500mg/dl) to patients with severe hypertriglyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to actually reduce LDL, or “bad cholesterol”, as well as the potential to increase HDL, or “good cholesterol”, especially at the therapeutic dose of 4 grams/day. The Phase 2 data also showed a significant reduction of HbA1c at a 4 gram dose, suggesting that due to its unique omega-3/phospholipid composition, CaPre may actually improve long-term glucose metabolism. Acasti’s TRILOGY Phase 3 program is currently underway.