Daiichi Sankyo Reports Positive Initial Results from Bempedoic Acid / Ezetimibe Study

Daiichi Sankyo Europe GMbH announced positive initial results from the 12-week Phase 2 bempedoic acid / ezetimibe fixed dose combination (FDC) tablet study (also known as Study 058). Bempedoic acid and its FDC tablet with ezetimibe are currently undergoing regulatory review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).

Study 058 evaluated the efficacy and safety of the bempedoic acid / ezetimibe FDC tablet compared to ezetimibe and placebo in patients with both hypercholesterolaemia and type 2 diabetes. Participants were on a background of stable diabetes medication.

The 12-week study met its primary endpoints as well as key secondary endpoints, including that the bempedoic acid / ezetimibe FDC tablet:

Significantly lowered Low-Density Lipoprotein Cholesterol (LDL-C) by 40% compared to placebo

Reduced high-sensitivity C-Reactive Protein (hsCRP), an important marker of inflammation associated with cardiovascular disease, by 25% (p<0.001)

Did not result in any difference in haemoglobin A1c (HbA1c) compared to placebo

Overall adverse events (AEs) comparable to placebo

Had no increase in muscle-related AEs, serious adverse events (SAEs), discontinuations due to AEs or elevations in liver function tests (LFTs)

Achieved LDL-C <70 mg/dl in 39% of patients and reduction of >50% in 41% of patients

Resulted in consistent reductions in additional lipid parameters such as apolipoprotein B and non-High-Density Lipoprotein Cholesterol (HDL-C).

"The LDL-C lowering and hsCRP reductions seen with the bempedoic acid / ezetimibe once-daily combination oral tablet, without worsening glycaemic parameters, are very important to physicians like me who frequently manage patients with both hypercholesterolaemia and type 2 diabetes. In addition, the substantial reductions in apolipoprotein B and non-HDL-C observed in this study may be particularly important for patients with hypercholesterolaemia and type 2 diabetes," said Dr Harold Bays, medical director and president of the Louisville Metabolic and Atherosclerosis Research Center. "Patients benefit from having more therapeutic options, especially ones that improve multiple cardiovascular disease risk factors."

Study 058 showed no clinical differences between the bempedoic acid / ezetimibe FDC tablet, placebo and ezetimibe groups in the occurrence of:

AEs with 43%, 37% and 30%, respectively

SAEs with 0%, 2% and 2%, respectively

Discontinuations due to AEs with 0%, 0% and 2%, respectively

No elevations in LFTs (alanine aminotransferase (ALT) /alanine aminotransferase (AST) greater than three times the upper limit of normal, repeated and confirmed) were observed.

"This study highlights the potential of this once-daily tablet to treat people with increasingly common metabolic conditions, who often struggle to reach targets suggested by clinical guidelines to provide maximum protection from cardiovascular events," said Wolfgang Zierhut, MD, Head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. "People living with type 2 diabetes are at increased cardiovascular risk, and as the incidence of type 2 diabetes across Europe continues to increase we need new options to help protect people trying to lower their cholesterol levels without compromising their glycaemic control."

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