Phase III CLEAR Wisdom study of ETC 1002 shows safe profile in dyslipidaemia

Daiichi Sankyo and Esperion announced that data from the Phase III CLEAR Wisdom study of ETC 1002 (bempedoic acid) highlighted the primary endpoint of LDL-C lowering at 12-weeks and key secondary endpoint of safety and tolerability over 52-weeks. The data showed that bempedoic acid significantly lowered LDL-C by 17% on background maximally tolerated statin therapy, and maintained significant reductions in LDL-C for 52 weeks. It also significantly lowered high sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 19%. Bempedoic acid also had an adverse event profile that was similar to that of placebo (70.1% vs 70.8%) and serious adverse event profile that was generally similar to that of placebo (20.3% vs 18.7%). Finally the drug showed no worsening of glycemic measurements in patients with a history of diabetes, including a 12-week reduction in haemoglobin A1c of 0.21%. Data were presented at the ACC Scientific Sessions & Expo in New Orleans.

Comment: There is a significant need for additional treatment options for the large number of patients in Europe with hypercholesterolemia who are not at their target LDL-C level. Even in very high-risk patients, only 32% are at their target LDL-C level. Bempedoic acid has a liver specific mode of action and therefore has the potential to avoid the muscle related adverse drug reactions associated with statin therapy. Bempedoic acid can be used in combination with other lipid lowering drugs and will offer an oral, once-daily option for patients not at target. Bempedoic acid is being developed as a complementary, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C). Bempedoic acid and the bempedoic acid / ezetimibe combination tablet new drug applications have been submitted to the FDA, and are under regulatory review for marketing authorisation by the European Medicines Agency (EMA).