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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
