Daiichi Sankyo has reported findings from the Phase III clinical trial of bempedoic acid / ezetimibe fixed-dose combination (FDC) tablet in hypercholesterolemia patients.
The FDC tablet is an oral ATP citrate lyase (ACL) inhibitor intended to minimise cholesterol synthesis in the liver. It is currently being reviewed by regulatory authorities in the US and EU.
Study 053 investigated the safety, efficacy, and tolerability of the therapeutic over 12 weeks in 382 patients who had a history of atherosclerotic cardiovascular disease or are at high-risk for the disease.
The trial enrolled subjects who were on maximally tolerated statin therapy. Participants received the FDC tablet, comprising 180mg bempedoic acid and 10mg ezetimibe, or placebo.
Study 053 has met its primary endpoint and key secondary endpoints, demonstrating a significant decrease of 38% in LDL-cholesterol and 35% in high-sensitivity C-reactive protein (hsCRP) compared to placebo.
The tablet was well-tolerated and showed a favourable safety profile when given with maximally tolerated statin therapy.
During the trial, the number of adverse events, serious adverse events, and discontinuations due to an event were observed to be similar to those in other active treatment arms.
Daiichi Sankyo Europe Antithrombotic and Cardiovascular Medical Affairs department head Wolfgang Zierhut said: “We are pleased to report the superior LDL-C and hsCRP lowering benefits versus placebo that the FDC of bempedoic acid with ezetimibe brings to patients at high risk of CVD who do not reach their target for LDL-C despite being on maximally tolerated statin therapy.
“These results add to the growing body of evidence supporting bempedoic acid and the bempedoic acid / ezetimibe FDC tablet.”
The results have been published in the European Journal of Preventative Cardiology.