About Acasti

Acasti Pharma is developing safe and effective pharmaceutical and medical applications with an initial focus on cardiovascular disease by leveraging the intellectual property, clinical data and know how developed by Neptune Technologies. The Company is advancing a portfolio of bioactive ingredients of proprietary novel omega-3 phospholipids through the pharmaceutical development pathway which includes prescription medical foods (MF), over-the-counter products (OTC), and prescription drugs (Rx). Phospholipids are the major component of cell membranes and essential for all vital cell processes. They are one of the principle constituents of High Density Lipoprotein (good cholesterol) and play, as such, an important role in modulating cholesterol efflux.

Acasti Pharma's proprietary novel phospholipids carry and functionalize the polyunsaturated omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) stabilized by potent antioxidants. Evidence has demonstrated the anti-inflammatory properties of EPA and DHA regulating important biological functions including degenerative, arthritic, circulatory, digestive, and brain diseases. Delivering omega-3s functionalized on phospholipids helps optimize the omega-3 fatty acid therapeutic benefits. Potent antioxidants contribute to proper physiological regulation preventing free radical cellular damage, a common pathway for cardiovascular disease and inflammation as well as neurodegenerative disease.

Neptune has carried out a number of clinical trials for various therapeutic indications using Neptune Krill Oil (NKO®), a patented composition containing the proprietary novel omega-3 phospholipids. A clinical multicenter, three-month, prospective, randomized, double blind clinical study has been carried out on 120 patients to assess the effectiveness in hyperlipidemia, a disease of abnormal levels of LDL (bad cholesterol), HDL (good cholesterol) and triglycerides. Hyperlipidemia promotes plaque formation and narrowing of the arteries leading to heart attack, stroke and peripheral vascular and neurodegenerative diseases.

The objective was to evaluate the effects of NKO® in monotherapy and in combination with low statin dose on total cholesterol, triglycerides, LDL and HDL levels compared to statins such as Lipitor®, standard fish oil and placebo. The study has shown that omega-3 functionalized phospholipids are effective in controlling hyperlipidemia by significantly reducing total cholesterol, LDL (bad cholesterol) and triglycerides, while increasing HDL (good cholesterol) to unmatched levels by competitors. These results were generated among statin-resistant patients who failed to attain the desired level of lipid serum after at least six months of low dose statin treatment.

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Current treatment focus has been mainly on lowering high levels of the bad cholesterol LDL. Treatment of choice are statins including brand names such as Lipitor®, Zocor® and Crestor® generating a worldwide statin market of over $30 billion. However statins have less effect than fibrates or niacin in raising HDL, the good cholesterol, now recognized as a major risk factor for developing cardiovascular disease. However, treatment options to raise HDL are very limited creating a treatment gap with an enormous unmet clinical need. The future market will be driven by increased use of combination therapies to raise HDL and new treatment options such as provided by omega-3/ phospholipids.

Acasti Pharma is negotiating with pharmaceutical companies for the medical food (MF), over-the-counter (OTC) and prescription drug (Rx) applications. Late stage clinical development for the prescription drug will be carried out with a corporate partner to mitigate development and financial risk.