Matinas BioPharma Announces Topline Results from ENHANCE-IT Study of LYPDISO™ Against Vascepa®
February 01, 2021 at 11:00 am
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Matinas BioPharma Holdings, Inc. announced topline results from the ENHANCE-IT study (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), the second head-to-head comparative study of LYPDISO™ vs. Vascepa®. In ENHANCE-IT, the key parameters evaluated included triglycerides (TGs), other lipoprotein and inflammatory markers, and blood levels of omega-3 fatty acids. The primary endpoint was the percent change from baseline to end-of-treatment in TG and superiority vs. Vascepa®. Analyses were performed on a Pharmacodynamic (PD) population (n=94; all subjects with evaluable measurements in the two-treatment period, regardless of compliance with study drug treatment), and a Per Protocol (PP) population (n=82; those subjects in the PD population where overall compliance in both treatment periods was at least 80% with no clinically important protocol violations or deviations).Plasma eicosapentaenoic acid (EPA) concentrations were statistically significantly higher with LYPDISO™, with a 46% relative percentage improvement in EPA blood level concentrations over Vascepa®. In the PD population there was a greater reduction in TGs with LYPDISO™ (21.9%) as compared with Vascepa (15.7%); this 39% relative improvement did not achieve statistical significance. In the PP population, there were statistically significant superior reductions in TGs, total cholesterol (TC), VLDL cholesterol (VLDL-C) and high sensitivity C-reactive protein (hsCRP), a well-established inflammatory marker.
Matinas BioPharma Holdings, Inc. is a biopharmaceutical company. The Company is focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology (LNC Platform). Its lead product candidate is MAT2203 (oral amphotericin B), a highly potent antifungal drug which, by virtue of LNC delivery, has been made oral, safe, and well-tolerated for prolonged administration in patients with life-threatening invasive fungal infections. MAT2203 is now positioned for a single, Phase III registration trial (the ORALTO trial) in support of a New Drug Application (NDA) for the treatment of invasive aspergillosis in patients with limited treatment options. It is expanding the utilization of the LNC Platform with small molecules and small oligonucleotides outside of infectious disease, targeting inflammation and oncology. It is also investigating a variety of LNC formulations of two small oligonucleotides designed to target inflammatory cytokines IL-17A and TNFα.