Espiron’s Phase II trial of their cholesterol-lowering bempedoic acid + ezetimibe combination drug in patients with type 2 diabetes has met its primary endpoint and key secondary endpoints after a 12-week study.
The drug combination was shown to significantly lower LDL-C by 40% compared to placebo and reduce high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation associated with cardiovascular disease, by 25%. There was no worsening of glycemic control.
The Phase II double-blind, parallel-group study enrolled 179 high cholesterol diabetic patients who were randomized to receive either the bempedoic acid + ezetimibe combination tablet, ezetimibe, or placebo. Patients enrolled were on stable background diabetes medications and washed out of lipid-modifying therapies. Safety and tolerability of the bempedoic acid/ezetimibe combination tablet over 12 weeks results showed no clinical differences between the bempedoic acid + ezetimibe combination tablet, placebo, and ezetimibe patient groups in the occurrence of adverse events.
This was an important outcome, as patients with both high cholesterol and type 2 diabetes pose a treatment challenge. Statins are usually used as the primary cholesterol-lowering drug, but they have been linked to increased blood sugar levels. Esperion’s combination drug could help eliminate these risks for Type 2 diabetes patients.
Bempedoic acid in combination with ezetimibe and as a monotherapy is awaiting approval by the US Food and Drug Administration, and has a PDUFA date of February 2020.