Acasti Pharma Provides Update On CaPre Phase III Development Program
Outcome of the End-of-Phase 2 Meeting with the FDA
Confirms Phase 3 Program is on Track to Start Late 2017
Laval, Québec, CANADA – March 30, 2017 – Acasti Pharma Inc. (NASDAQ:ACST – TSX-V:ACST) today announced its plans to proceed with its Phase 3 development program for CaPre® (omega-3 phospholipid), following the company’s recent end-of-Phase 2 meeting with the U.S. Food and Drug Administration. CaPre is a potentially best-in-class omega-3 drug derived of krill oil being developed for the treatment of patients with hypertriglyceridemia, a metabolic condition that contributes to the risk of cardiovascular disease and pancreatitis.
Acasti plans to conduct two pivotal, randomized, placebo controlled studies to evaluate the efficacy and safety of CaPre in patients with severe hypertriglyceridemia (very high triglyceride levels =500 mg/dL). The studies will evaluate the ability of CaPre to lower triglycerides from baseline in approximately 400 patients randomized to either CaPre 4g daily or placebo. The regulatory agency’s feedback supports Acasti’s plan to conduct two studies instead of one large study, potentially shortening the time to New Drug Application (NDA) submission.
“With the FDA’s guidance, we’ve charted the course for our registration program for CaPre. This represents an important milestone in our aspiration to provide a differentiated omega-3 therapeutic for the large population of patients with hypertriglyceridemia,” said Jan D’Alvise, president and CEO of Acasti Pharma. “We are also making excellent progress on completing the production of the CaPre clinical trial product in preparation for the anticipated initiation of the Phase 3 program in the second half of 2017.”
Acasti’s development program will be designed to satisfy the requirements of the 505(b)(2) regulatory pathway for a NDA. This program will allow Acasti to demonstrate CaPre’s clinical benefits, while leveraging the substantial clinical and nonclinical safety data already available with LOVAZA (omega-3-acid ethyl esters), an already-approved omega-3 prescription drug.
CaPre is designed to modulate the unhealthy levels of the major lipids that can be associated with cardio-metabolic disease. In four clinical trials conducted to date, Acasti saw the following beneficial effects with CaPre:
• Significant reduction of triglycerides and non-high density lipoprotein cholesterol (non-HDL-C) levels in the blood of patients with mild to severe hypertriglyceridemia;
• No deleterious effect on low-density lipoprotein cholesterol, or “bad” cholesterol (LDL-C), and potential to reduce LDL-C;
• Potential to increase high-density lipoprotein cholesterol, or “good” cholesterol (HDL-C);
• Good bioavailability without significant food effect, important considerations for patients with metabolic disease who should be on a low fat diet and;
• An overall safety profile similar to that of currently marketed omega-3s, with the added potential for beneficial LDL-C effect.
About CaPre (omega-3 phospholipid)
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 that help them to be better absorbed into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the “esterified” fish-oil omega-3 options such as LOVAZA.
About Acasti Pharma
Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. The corporation’s strategy is to initially develop and commercialize CaPre for the three to four million patients in the U.S. with severe hypertriglyceridemia. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. For more information, visit www.acastipharma.com.
Confirms Phase 3 Program is on Track to Start Late 2017
Laval, Québec, CANADA – March 30, 2017 – Acasti Pharma Inc. (NASDAQ:ACST – TSX-V:ACST) today announced its plans to proceed with its Phase 3 development program for CaPre® (omega-3 phospholipid), following the company’s recent end-of-Phase 2 meeting with the U.S. Food and Drug Administration. CaPre is a potentially best-in-class omega-3 drug derived of krill oil being developed for the treatment of patients with hypertriglyceridemia, a metabolic condition that contributes to the risk of cardiovascular disease and pancreatitis.
Acasti plans to conduct two pivotal, randomized, placebo controlled studies to evaluate the efficacy and safety of CaPre in patients with severe hypertriglyceridemia (very high triglyceride levels =500 mg/dL). The studies will evaluate the ability of CaPre to lower triglycerides from baseline in approximately 400 patients randomized to either CaPre 4g daily or placebo. The regulatory agency’s feedback supports Acasti’s plan to conduct two studies instead of one large study, potentially shortening the time to New Drug Application (NDA) submission.
“With the FDA’s guidance, we’ve charted the course for our registration program for CaPre. This represents an important milestone in our aspiration to provide a differentiated omega-3 therapeutic for the large population of patients with hypertriglyceridemia,” said Jan D’Alvise, president and CEO of Acasti Pharma. “We are also making excellent progress on completing the production of the CaPre clinical trial product in preparation for the anticipated initiation of the Phase 3 program in the second half of 2017.”
Acasti’s development program will be designed to satisfy the requirements of the 505(b)(2) regulatory pathway for a NDA. This program will allow Acasti to demonstrate CaPre’s clinical benefits, while leveraging the substantial clinical and nonclinical safety data already available with LOVAZA (omega-3-acid ethyl esters), an already-approved omega-3 prescription drug.
CaPre is designed to modulate the unhealthy levels of the major lipids that can be associated with cardio-metabolic disease. In four clinical trials conducted to date, Acasti saw the following beneficial effects with CaPre:
• Significant reduction of triglycerides and non-high density lipoprotein cholesterol (non-HDL-C) levels in the blood of patients with mild to severe hypertriglyceridemia;
• No deleterious effect on low-density lipoprotein cholesterol, or “bad” cholesterol (LDL-C), and potential to reduce LDL-C;
• Potential to increase high-density lipoprotein cholesterol, or “good” cholesterol (HDL-C);
• Good bioavailability without significant food effect, important considerations for patients with metabolic disease who should be on a low fat diet and;
• An overall safety profile similar to that of currently marketed omega-3s, with the added potential for beneficial LDL-C effect.
About CaPre (omega-3 phospholipid)
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 that help them to be better absorbed into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the “esterified” fish-oil omega-3 options such as LOVAZA.
About Acasti Pharma
Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. The corporation’s strategy is to initially develop and commercialize CaPre for the three to four million patients in the U.S. with severe hypertriglyceridemia. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. For more information, visit www.acastipharma.com.