Phase III study (Study 1 or 1002-040) of bempedoic acid as a treatment for atherosclerotic cardiovascular disease.- Esperion.

Esperion has announced positive top-line results from the second pivotal, Phase III study (Study 1 or 1002-040) , the long-term safety study of bempedoic acid 180 mg, in this case evaluating the safety, tolerability and efficacy of bempedoic acid versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy. The study included 2,230 patients and met the primary endpoint of safety and tolerability and the key efficacy endpoint with on-treatment LDL-C lowering of an additional 20 percent at twelve weeks (p<0.001) 18 percent p><0.001) in the intent to treat analysis. patients treated with bempedoic acid also achieved a significant reduction of 22 percent in high-sensitivity c-reactive protein hscrp an important marker of the underlying inflammation associated with cardiovascular disease.>

Long-Term Safety and Tolerability of Bempedoic Acid over 52 Weeks: In this 52-week study, bempedoic acid was observed to be safe and well-tolerated. There were no clinically relevant differences between the bempedoic acid and placebo groups in the occurrence of adverse events (AEs) with 78.5 percent and 78.7 percent, respectively; or serious adverse events (SAEs) with 14.5 percent and 14.0 percent, respectively. Discontinuations due to AEs were 10.9 percent and 7.1 percent, respectively for the bempedoic acid and placebo groups; discontinuations due to muscle-related AEs were 2.2 percent and 1.9 percent, respectively in the bempedoic acid and placebo groups. In the study, 0.54 percent of patients treated with bempedoic acid and 0.13 percent of patients in the placebo group had elevations in liver function tests (ALT/AST) of greater than three times the upper limit of normal, repeated and confirmed. The cumulative number of patients now treated with bempedoic acid in Phase II and Phase III clinical trials totals 2,434. Of these, 0.58 percent had elevations in liver function tests greater than three times the upper limit of normal, repeated and confirmed. This rate of elevations in liver function test is consistent with the rate observed in all other previously approved oral LDL-C-lowering therapies, including statins and ezetimibe.

LDL-C Lowering and hsCRP Reduction: The study met its key efficacy endpoint with on-treatment LDL-C lowering of 20 percent at 12 and 24 weeks, and 16 percent at 52 weeks (p<0.001). the ldl-c lowering for the bempedoic acid group at 12 weeks was 18 percent from baseline as compared to an ldl-c increase of two percent for the placebo group. the intent to treat ldl-c lowering totaled 18 percent p><0.001) at 12 weeks. these results were comparable across statin treatment groups. patients treated with bempedoic acid also achieved a significant reduction of 22 percent in hscrp compared to the placebo group which had an increase of three percent p><0.001). esperion plans to present full results from this study at an upcoming medical conference and to publish in a major medical journal.>

Comment:-Esperion revealed data from the Study 1 or 1002-040 of bempedoic acid showing there were more patient deaths in the study's treatment arm than its control arm.Two patients on placebo died during the clinical investigation versus 13 treated with Esperion's bempedoic acid. Discontinuation due to adverse events was also higher among those receiving the bempedoic acid , however Esperion said the deaths were not related to treatment with its drug.