“After several years of development and positive outcomes from multiple Phase 2 and pharmacokinetic studies of SC401, we are now prepared to conduct our pivotal Phase 3 trial for the treatment of severe hypertriglyceridemia."
Riviera Beach, FL (PRWEB) December 11, 2013
Sancilio and Company, Inc. (SCI) today announced its submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a pivotal Phase 3 study of its lead investigational drug, SC401™. SC401 is a combination of highly refined eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) formulated with SCI’s proprietary Advanced Lipid Technology™ platform to enhance bioavailability, eliminate the significant food effect exhibited by EPA/DHA and EPA-only therapies, and reduce the side effects commonly associated with such therapies.
“After several years of development and positive outcomes from multiple Phase 2 and pharmacokinetic studies of SC401, we are now prepared to conduct our pivotal Phase 3 trial for the treatment of severe hypertriglyceridemia, a condition estimated to affect 3.4 million Americans,” said Frederick D. Sancilio, PhD, Founder and CEO of SCI. “We believe that due to its novel formulation, SC401 has the potential to overcome the challenges of currently available therapies, including poor absorption and significant bioavailability variances, to better meet the needs of this underserved patient population.”
The objective of the proposed randomized, double-blind, placebo-controlled study is to evaluate the effects of the daily administration of SC401 at three dose levels (1.2 grams, 2.5 grams and 3.8 grams of EPA/DHA) in 276 subjects with serum triglyceride levels between 500 mg/dL and 2,000 mg/dL (severe hypertriglyceridemia). The primary objective of the study is to evaluate the difference in the percent change of triglyceride reduction between the three doses of SC401 and placebo from baseline to week 12. The secondary endpoints include percent change from baseline to week 12 for total cholesterol, LDL-C, HDL-C, and non-HDL-C. Additional exploratory variables include VLDL-C, LDL-C particle size, apolipoprotein (Apo) A1, Apo B, Apo C-III and lipoprotein-associated phospholipase A2 (Lp-PLA2).
Triglycerides are fats that are carried in the blood, together with cholesterol within lipoproteins. The National Cholesterol Education Program Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol recommends that the first priority for the management of severe hypertriglyceridemia be triglyceride reduction to decrease the risk of pancreatitis. Severe hypertriglyceridemia is also associated with markedly increased risk for cardiovascular disease, and recent studies have demonstrated that elevated triglyceride levels can be regarded as an independent risk factor for cardiovascular disease-related events such as myocardial infarction, ischemic heart disease and ischemic stroke.
Current EPA/DHA and EPA-only therapies for the treatment of severe hypertriglyceridemia are poorly absorbed by the body, in part due to a significant food effect. The result is that patients must take four large capsules per day, split into twice-daily dosing, and that each dose must be taken with a meal. Furthermore, bioavailability studies demonstrate large variances in absorption based on the fat content of the pre-dosing meal, with high-fat meals resulting in increased absorption and low-fat meals exhibiting a decreased absorption profile that is similar to fasted dosing. SCI’s Advanced Lipid Technologies have proven in clinical studies to provide a platform by which the EPA and DHA contained in SC401 are absorbed by the body at the same rate regardless of whether dosing takes place with or without a meal, or whether a pre-dosing meal is high- or low-fat. In addition, SC401 achieved higher levels of EPA and DHA absorption as compared with current EPA and DHA therapies when those therapies are dosed with high-fat meals.
Sancilio continued, “Our previous SC401 clinical trials demonstrated that by eliminating the food and ‘fat’ effects found in current EPA/DHA and EPA-only therapies, SC401 has the potential to treat severely hypertriglyceridemic patients with two, or perhaps even one capsule a day, while achieving equal or greater efficacy than that achieved by those therapies. We anticipate that SC401 will eliminate the need to dose with a meal, in particular the high-fat meal required of current EPA/DHA and EPA-only therapies.
“The proprietary Advanced Lipid Technologies that were used to formulate SC401 have the potential to deliver a host of lipid-based materials, including EPA and DHA, where effective therapies are currently unattainable due to low bioavailability. We have several additional product candidates in our pipeline that will address some of those opportunities,” Sancilio concluded.
About Sancilio and Company, Inc.
Sancilio and Company, Inc. (SCI) is a vertically integrated, profitable, specialty pharmaceutical company founded by Dr. Frederick D. Sancilio. SCI applies proprietary Advanced Lipid Technologies (ALT) to existing prescription and over-the-counter products, particularly omega-3 and hormone products in soft gelatin dosage forms, to enhance bioavailability, decrease dose and/or expand application of the products to new indications. SCI’s products are developed, tested, manufactured, marketed and distributed at its Florida facility. In addition, SCI partners with large, global and small, virtual drug companies to co-develop both branded and generic drugs in soft gelatin dosage forms, which are then manufactured by SCI.
SCI’s research and development pipeline includes multiple prescription drug products formulated with its ALT, including SC401, its investigational EPA/DHA product for the reduction of triglycerides. SCI’s Ocean Blue© family of omega-3 products is sold in over 20,000 pharmacies across the United States, including through CVS, Walgreens, Rite Aid, Publix and Winn Dixie, as well as internationally. For more information about SCI, please visit http://www.sancilio.com and http://www.oceanblueprofessional.com.