Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre®, for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one-third of the U.S. population.
Established in August 2008, Acasti is focused on addressing an important market need for an effective, safe and well-absorbed omega-3 therapeutic that can address a patient’s lipid profile — making a positive impact on the major lipids associated with cardiovascular disease risk.
President and CEO
Acasti’s Phase 3-ready investigational candidate CaPre® will be the first pharmaceutical omega-3 product sourced from krill oil. CaPre® has successfully completed phase 1 and 2 trials for the treatment of hypertriglyceridemia, a common metabolic condition characterized by high levels of triglycerides in the blood stream.
The American Heart Association has estimated that one-third of the U.S. population has elevated levels of triglycerides.
CaPre’s concentrated omega-3s from krill oil are absorbed into the body more efficiently than those from fish oils, enhancing bioavailability and providing benefits to a patient’s total lipid profile. That means that CaPre® doesn’t just lower triglycerides; it also has shown in clinical trials to have beneficial effects on “good” and “bad” cholesterol levels that affect heart health.
Laval, Québec, CANADA, Sept. 14, 2016 — Acasti Pharma (NASDAQ:ACST – TSX-V:APO) today announced that its bridging study for novel drug candidate CaPre® (omega-3 phospholipid) has successfully met its objectives, supporting Acasti’s strategy to pursue the U.S. Food and Drug Administration’s (FDA) 505(b)(2) regulatory pathway for approval. Acasti is developing CaPre for the treatment of patients with severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. The 505(b)(2) regulatory pathway allows Acasti to streamline the overall development program required to support a New Drug Application (NDA) by relying on the safety data of an approved drug.
Laval, Québec, CANADA, October 26, 2016 — Acasti Pharma (NASDAQ:ACST – TSX-V:APO) today announced that the United States Patent and Trademark Office issued Acasti a patent (U.S. patent no. 9,475,830) directed to a method of treating hypertriglyceridemia by the administration of a concentrated phospholipid composition.
This newly issued patent expands Acasti’s intellectual property portfolio related to concentrated therapeutic phospholipid omega-3 compositions covering methods for treating or preventing diseases associated with or related to cardiovascular disease.