Acasti has an exclusive licence from Neptune to develop pharmaceutical products customized to manage cardiovascular disease.  CaPre® is currently Acasti’s only prescription drug candidate, and is being developed to  address the prevention and  treatment of cardiometabolic disorders including hypertriglyceridemia, a condition which is characterized by abnormally high levels of triglycerides. 

CaPre® is composed of a patent-protected highly concentrated novel omega-3 phospholipid derived from krill oil for the prevention and treatment of certain cardiometabolic disorders.  The active ingredient of CaPre® is a mixture of  concentrated omega-3 fatty acids purified from krill oil and developed as an oral formulation. CaPre® contains EPA and DHA bound to phospholipids as well as free EPA and DHA.  

Acasti’s near-term strategy is  to develop and commercialize CaPre® in the  United States as a prescription drug with a claim for the treatment of severe hypertriglyceridemia and, as a next step, the treatment of mild to moderate hypertriglyceridemia. 

Going forward Acasti hopes, CaPre® can be used as a therapy in conjunction with positive lifestyle changes and administered either alone or with other treatments such as statins (statins are a class of drug used to reduce cholesterol levels) and potentially for use by statin-intolerant or statin-resistant patients. 

Acasti initiated two Phase II clinical trials designed to evaluate the safety and efficacy of CaPre® for the management of hypertriglyceridemia. These trials are a central part of its US and international regulatory compliance program and  are an essential step in securing regulatory approval to distribute and market CaPre® as a prescription drug in the pharmaceutical marketplace.  Acasti has successfully completed both Phase II trials.  Obtaining regulatory approval for CaPre® requires that safety and efficacy in reducing triglycerides is confirmed.

There are competing products in the marketplace to treat hypertriglyceridemia, including products that have been manufactured from omega-3 fish oil, and products that, if approved, would compete with CaPre®.  However, considerable medical needs remain in the multi-billion dollar hypertriglyceridemia market.  Market participants, including the American Heart Association, have estimated that one-third of the US population has elevated levels of triglycerides.  Acasti believes that there will be increased growth in the prescription omega-3 market based on the expected introduction, and resulting increased promotion and awareness, of new prescription omega-3 products, as well as the emergence of new clinical data regarding the efficacy of omega-3 in the treatment and prevention of cardiometabolic disorders.