Esperion reports Phase III data for hypercholesterolemia candidate
Esperion Therapeutics Inc. (NASDAQ:ESPR) said bempedoic acid (ETC-1002) met the primary safety endpoint and key secondary efficacy endpoint in the Phase III CLEAR Harmony (1002-040) trial to treat high-risk atherosclerotic cardiovascular disease (ASCVD) patients with hypercholesterolemia, but also reported a higher incidence of fatal adverse events in the active arm compared with placebo.
Esperion reported a rate of fatal adverse events that were unrelated to study treatment of 0.9% in the bempedoic acid arm compared with 0.3% in the placebo arm. The rate of discontinuation due to adverse events was 10.9% in the bempedoic acid arm vs. 7.1% in the placebo arm, and the rate of serious adverse events was similar between treatment arms (14.5% vs. 14%). The company also reported that eight patients in the bempedoic acid arm had liver enzyme elevations that were more than three times the upper limit of normal...
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