Matinas BioPharma Holdings, Inc. (NYSE: MTNB), today announced that it has initiated the ENHANCE-IT Study (Pharmacodynamic Effects of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), a head-to-head pharmacodynamic (PD) study of MAT9001 against Vascepa® in patients with elevated triglycerides (150-499 mg/dL). The ENHANCE-IT study will assess MAT9001’s effectiveness in reducing triglyceride levels and other important lipid markers, as well as gather important data on bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids.

“The ENHANCE-IT study is a significant next step in our clinical development program designed to highlight the impressive efficacy of MAT9001 and further distinguish its superior profile from Vascepa,” commented James J. Ferguson, M.D., Chief Medical Officer of Matinas. “Following recent developments in the omega-3 space which we believe limit potential competition, MAT9001 is well-positioned to potentially become an integral part of the treatment and prevention of cardiovascular and metabolic disease. Initiating ENHANCE-IT in a timely fashion was one of our key corporate priorities and we look forward to reporting topline results from this clinical trial in the fourth quarter of 2020.”

“ENHANCE-IT will provide key information about MAT9001 and Vascepa. Elevated triglycerides continue to represent an important modifiable risk factor for cardiovascular disease, and we also need to better understand the potential mechanistic drivers behind the established benefits of omega-3 therapy,” commented Kevin C. Maki, Ph.D., President and Chief Scientist of Midwest Biomedical Research. “Given the potential importance of the association of higher EPA blood levels with the cardiovascular risk reduction seen with Vascepa in the REDUCE-IT trial, this second head-to-head study of MAT9001 against Vascepa could have very important implications.”

ENHANCE-IT is an open-label, randomized, 28-day crossover study to assess the PD effects of MAT9001 vs. Vascepa. The study will enroll approximately 100 adult men and women with elevated triglycerides (150-499 mg/dL), with at least 50% of study subjects with TGs ≥ 200 mg/dL. The study consists of two 28-day treatment periods, with a washout period of at least 28-days between treatments and will be conducted at approximately eight sites in the United States. MAT9001 and Vascepa will each be administered twice daily with food in accordance with currently approved Vascepa labeling. Measurements of lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9) and omega-3 blood levels will be obtained at each baseline and at the end of each treatment period. The primary endpoint is the percent change from baseline to end-of-treatment in plasma triglycerides.