By Alex Keown
Ann Arbor, Mich.-based Esperion Therapeutics is starting off the week with several positives. The company first reported final results from a long-term safety study of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) whose disease is inadequately controlled by statins.
Data from that study, presented at the European Society of Cardiology (ESC) Congress in Munich, showed patients on bempedoic acid who were on a maximally tolerated statin dose had “significantly fewer instances of new-onset or worsening diabetes than those on placebo.” Topline results from this trial were initially announced in May.
But that wasn’t the only news the company reported. Esperion also reported news from another Phase III study that showed a combination of bempedoic acid and ezetimibe significantly reduced LDL-C by 35 percent in patients who are currently on “maximally tolerated statins.” Not only that, but Esperion said the combination pill was able to lower LDL-C in patients who are considered statin intolerant by 43 percent. The combination pill was compared to bempedoic acid, ezetimibe or placebo in patients treated with maximally tolerated statins, the company reported.
The study included 382 high-risk patients who were taking maximally tolerated statins who required additional LDL-C lowering. In the intent to treat analysis, LDL-C lowering was 32 percent for the combination pill compared to 3 percent for placebo, 21 percent for ezetimibe and 18 percent for bempedoic acid, Esperion said this morning. Additionally, 35 percent of patients saw a lowering of their LDL-C at 12 weeks, compared to 3 percent for placebo, 24 percent for ezetimibe and 20 percent for bempedoic acid.
Esperion also noted that the combination pill provided a 34 percent reduction in high-sensitivity C-reactive protein (hsCRP), which is an important marker of the underlying inflammation associated with cardiovascular disease. That reduction was compared with an increase in placebo of 4 percent and reductions of 20 percent for bempedoic acid and 9 percent for ezetimibe, the company said.
“I’m pleased to see the positive safety and tolerability profile of the bempedoic acid/ezetimibe fixed-dose combination pill which was similar to that of ezetimibe alone,” Christie M. Ballantyne, chairman of Esperion’s Phase III Executive Committee and chief of cardiology at Baylor College of Medicine said in a statement. “The LDL-C lowering and hsCRP reductions seen with the combination are very important to physicians like me who see these challenging patients every day, and we need more options for them.”
Esperion said the Phase III, four-arm study design included a primary endpoint of lowering LDL-C, as well as an abbreviated 505(b)(2) regulatory pathway that was agreed upon by the U.S. Food and Drug Administration (FDA) in 2017. Esperion plans to submit New Drug Applications to the FDA for bempedoic acid and the bempedoic acid/ezetimibe combination pill for LDL-C-lowering indications during the first quarter of 2019, the company said. Additionally, Esperion noted that it plans to submit Marketing Authorization Applications to the European Medicines Agency (EMA) during the second quarter of 2019.