Matinas BioPharma Announces Topline Results from ENHANCE-IT Study of LYPDISO™ Against Vascepa
BEDMINSTER, NJ, USA I February 01, 2021 IMatinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today 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.
“In this ENHANCE-IT study, LYPDISO™ achieved significantly higher EPA levels, and lowered triglycerides as well as hsCRP levels to a greater extent than Vascepa®,” said John J.P. Kastelein, M.D., Ph.D., Matinas Scientific Advisory Board member and Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, The Netherlands. “The REDUCE-IT outcomes trial with Vascepa® has shown that achieved EPA levels drive the cardiovascular protection conferred by omega-3 fatty acids. The impressive biomarker changes in ENHANCE-IT with LYPDISO™ support a potential robust protection against cardiovascular disease in a pivotal Phase 3 outcome program.”
01 February 2021
https://pipelinereview.com/i
