Esperion announces completion of Phase 3 LDL-C lowering development program
Esperion announced completion of the Phase 3 LDL-C Lowering Development Program of bempedoic acid and positive cumulative results. The program consisted of four, pivotal, Phase 3, randomized, double-blind, placebo controlled studies to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid 180 mg compared to placebo in high cardiovascular risk patients including atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia patients. The Phase 3 program included 3,621 high cardiovascular risk patients taking maximally tolerated statin who required additional LDL-C lowering. The Program achieved its efficacy endpoints and other key measures at 12 weeks for bempedoic acid, including: on-treatment LDL-C lowering of an additional 18% to 31%, and in the intent to treat analysis, LDL-C lowering of an additional 17% to 28%; reductions of 19% to 33% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease; reductions in hemoglobin A1c of 0.19% to 0.31% versus placebo in the subset of 1002 patients with diabetes. In the Phase 3 program, bempedoic acid was observed to be safe and well-tolerated. The vast majority of patients were studied for 52 weeks. Across the program there were no clinically relevant differences between the bempedoic acid and placebo treatment groups in the occurrence of adverse events with 73% in each group; serious adverse events with 14% and 13%, respectively; SAE neoplasms were balanced at 1% in both arms; discontinuations due to AEs with 11% and 8%, respectively; fatal adverse events were very low overall at 0.8% and 0.3%, respectively.