Benzinga | Nov 16, 2020 10:41AM EST

Amarin Shares Quiet For Earlier Pre-Market Session, Now Up 5.6%; Partner For Vascepa, HLS, Earlier Issued Press Release Highlighting VASCEPA Found To Significantly Reduce Ischemic Events In Patients With Prior Coronary Artery Bypass Grafting Procedures

HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, reported today on the presentation of REDUCE-IT(r) Coronary Artery Bypass Grafting ("CABG") analysis at the American Heart Association's ("AHA") Virtual Scientific Sessions 2020, being held virtually from November 13-17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA(r) (icosapent ethyl). These new analyses were presented by Subodh Verma, M.D., Ph.D., a cardiac surgeon and Professor at the University of Toronto, Toronto, Ontario, Canada.

Dr. Subodh Verma, who was the lead author of this analysis, commented: "The analyses from REDUCE-IT indicate that VASCEPA (icosapent ethyl) reduces the need for CABG (commonly referred to as bypass surgery) by about 40%. Furthermore, in patients who have undergone CABG surgery this therapy profoundly reduces subsequent major cardiovascular events of cardiovascular death, heart attack or stroke by 31%. These data have important implications for our patients and the health care system."

"The REDUCE-IT CABG analysis results are another piece of the puzzle when looking at the potential use of icosapent ethyl in the procedural setting," commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT. "The findings of benefit in at-risk patients with prior CABG are consistent with previously presented data on overall reductions in first and total coronary revascularization events, as well as in patients with prior percutaneous coronary interventions, and further strengthen the case for consideration of icosapent ethyl as an additional intervention for use by physicians to care for this patient population."

The REDUCE-IT CABG analysis looked at 1,837 (22.5%) of the patients enrolled in REDUCE-IT1, representing all patients who had undergone a prior CABG procedure, a common form of surgical intervention to help treat coronary heart disease. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of this subgroup showed that, for the composite endpoint of 5-point MACE, which was the prespecified primary endpoint for the full REDUCE-IT study cohort, time to first event for Vascepa was significantly better than placebo by 24% (p=0.004) and total (first and subsequent) events were also better by 36% (p=0.0002). For the REDUCE-IT study's key secondary composite endpoint of 3-point MACE, time to first event was better than placebo by 31% (p=0.001) in the subgroup of patients with a prior CABG.

Coronary revascularization procedures, such as CABG, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting.

REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.

These REDUCE-IT CABG results follow multiple scientific presentations of analysis results from other important patient subgroups in the REDUCE-IT study, including REDUCE-IT REVASC2 and REDUCE-IT PCI.

Additional information on AHA Virtual Scientific Sessions 2020 can be found here.