Third Phase III study of bempedoic acid in high-risk patients with atherosclerotic cardiovascular disease. Esperion Therapeutics.

Esperion announced positive top-line results from the third of five pivotal Phase III studies (Study 3 or 1002-046) expected to be reported this year. This study evaluated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD), or at high risk for ASCVD with hypercholesterolemia, inadequately treated with maximally tolerated background LDL-C lowering therapy who are only able to tolerate less than the approved daily starting dose of a statin and considered statin intolerant. Importantly, these results are consistent with the previously reported results in patients considered statin intolerant.

The 24-week study achieved LDL-C lowering totaling 26 percent in patients on bempedoic acid who remained on treatment at both week 12 and week 24 (an absolute reduction of 43 mg/dL) compared with placebo which had a decrease of two percent (p<0.001). the study met its primary endpoint with ldl-c lowering of 23 percent at 12 weeks in the intent to treat itt analysis an absolute reduction of 39 mg dl compared with placebo which had a decrease of one percent p><0.001). patients treated with bempedoic acid also achieved a significantly greater reduction of 25 percent in high-sensitivity c-reactive protein hscrp an important marker of the underlying inflammation associated with cardiovascular disease compared with placebo which had an increase of three percent p><0.001).>

In this study in statin-intolerant patients, bempedoic acid was observed to be safe and well-tolerated and with no fatalities observed in either group. Importantly, muscle-related adverse events were lower in the bempedoic acid group than in the placebo group. There were no clinically relevant differences in the occurrence of adverse events (AEs) and no differences between the treatment group and the placebo group in discontinuations due to muscle-related AEs which are commonly associated with statin intolerance. Serious adverse events (SAEs) in the bempedoic acid arm were 6.0 percent compared to 3.6 percent in the placebo arm. None of the SAEs were deemed to be related to bempedoic acid by the study investigator. Discontinuations due to AEs were 18.4 percent and 11.7 percent, respectively, for the treatment and placebo groups; importantly, there was no single class of events or event that was responsible for the difference. The rate of elevations in liver function tests in this study was 0.43 percent, repeated and confirmed. This is consistent with the 0.56 percent rate observed across the entire program and with all other previously approved and successful oral LDL-C lowering therapies, including statins and ezetimibe.