HLS Therapeutics highlights data on RESPECT-EPA study

HLS Therapeutics (HLTRF) highlighted key data presented at the American Heart Association 2022 Scientific Sessions relevant to VASCEPA related to RESPECT-EPA, A Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy – Statin and Eicosapentaenoic Acid. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation. In 2005, the Japan EPA Lipid Intervention study first demonstrated a beneficial effect of highly purified EPA on cardiovascular outcomes in patients with or without coronary artery disease. In 2019, Amarin Corporation (AMRN) published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TG levels. And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD. The late breaking data presented at AHA using 1.8 grams per day of purified EPA is consistent with the substantial body of evidence from the REDUCE-IT and JELIS trials, which showed that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high- and very high-risk statin-treated patients. Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk and achieved a statistically significant 26.6% reduction in the secondary composite endpoint of RESPECT-EPA. EPA level matters. In addition, a post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint. Other data presented at AHA 2022 support sustained low-density lipoprotein antioxidant effects for EPA in vitro compared with docosahexaenoic acid or mineral oil. The researchers concluded that the longer-term antioxidant actions of EPA may contribute to reduced events independent of placebo selection. Additional in vitro data presented at the meeting found that neither mineral oil nor corn oil affected rates of LDL oxidation, a central mechanism of atherosclerosis, even at high concentrations. HLS has in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin.