A phase 2 trial of Esperion’s bempedoic acid-ezetimibe combination in Type 2 diabetics with high cholesterol has met its primary endpoint. The trial provides evidence that the combination, which is under review at the FDA, can lower cholesterol without negatively affecting blood sugar levels.
People who have both high cholesterol, known as hypercholesterolemia, and Type 2 diabetes pose a treatment challenge. Studies have linked the use of statins, the go-to cholesterol-lowering drug, to increased blood sugar, particularly in people who already have elevated glycemic parameters. While the benefits may still outweigh the risks, FDA took the issue seriously enough to add the blood sugar effect to the labels of statins in 2012.
Esperion wants to eliminate the risks altogether. In a phase 2 trial, Esperion enrolled 179 diabetics with high cholesterol and randomized them to receive its combination, placebo or ezetimibe, a statin sold under the brand name Zetia, as a monotherapy.
After 12 weeks, Esperion saw “no worsening of glycemic control” in the cohort that received its drug combination. The study also met its co-primary endpoints, which compared LDL cholesterol levels in the combination cohort to the placebo and monotherapy arms. The combination reduced levels of LDL cholesterol by 40% over placebo. Esperion is yet to share the comparison to ezetimibe.
With the trial also linking the combination to a 25% reduction in high-sensitivity C-reactive protein and a clean safety profile, the data give Esperion another source of evidence to draw on as it prepares to bring its drug to market. Bempedoic acid, with and without ezetimibe, is awaiting approval by the FDA, which has set the PDUFA date for February 2020.
Shares in Esperion have fallen by around 30% over the past three months. The decline began in earnest after Esperion entered into a $200 million funding agreement in June. The deal is a staggered loan, which granted Esperion $125 million upfront with up to $75 million to follow as bempedoic acid wins FDA approval and comes to market.