Esperion’s stock is sliding south Wednesday morning following news that the company’s high cholesterol drug may have some safety concerns.
Overall, the company reported positive results from its Phase III trial of the drug, called bempedoic acid. The therapy met its primary endpoint on safety while lowering patients’ bad cholesterol by 20% over 12 weeks. But that wasn’t enough to appease investors, as the safety data raised a few eyebrows.
In a study that included 2,200 patients, roughly 1% getting Esperion’s treatment died (the company says causes were unrelated to the treatment). But only 0.3% of patients on the placebo died. That might be cause for concern at the FDA, which tends to err on the side of caution when considering drugs for a large patient population — and high cholesterol is anything but rare.
As long as late-stage data coming in September are positive, Esperion plans to file its NDA in early 2019. The plan is to tackle the middle of the market, offering a treatment that may be superior to generic (and cheap) statins, but not quite as expensive as the PCSK9 therapies from Regeneron/Sanofi and Amgen that go for about $14,000. In contrast, Esperion’s bempedoic acid might go for about $4,000, if approved.
“In the coming months, results from our three remaining pivotal Phase III studies are expected to further validate the safety, efficacy and tolerability profile of bempedoic acid and the bempedoic acid/ezetimibe combination pill, definitively establishing these once-daily oral therapies as convenient and complementary to existing treatments for the 13 million people in the US with atherosclerotic cardiovascular disease,” said Tim Mayleben, Esperion president and CEO, in a statement.
Esperion’s stock $ESPR is down 30% in pre-market trading, selling at $49.70 per share as of press time.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 32,300+ biopharma pros who read Endpoints News by email every day.Free Subscription