Esperion, without data, says cholesterol pill lowered heart risk in study – BioPharma Dive

A cholesterol pill developed by drugmaker Esperion Therapeutics reduced heart risk in a large international study of more than 14,000 people, suggesting the medicine could be another addition to cardiologists’ toolkit beyond statins and injectable treatments.

In a short Wednesday statement, Esperion said treatment with its medicine led to a significant and “clinically meaningful” lowering in the risk of major cardiovascular events like heart attack or stroke when compared to a placebo. But the company disclosed no other details or specific data, saying only that it looks forward to sharing results with the medical community and regulators next year.

Shares in Esperion, a small, Ann Arbor, Michigan-based biotechnology company, initially rose by nearly 20% Wednesday morning, before falling back to trade down slightly.

The trial, dubbed CLEAR Outcomes, is a major test for Esperion, which bet that doctors and patients would be drawn to a middle option for lowering cholesterol between generic statin medicines and more expensive injections like Amgen’s Repatha. Its drug, called Nexletol, won U.S. approval in early 2020 for use on top of a maximum dose of statins in adults with a genetic form of high cholesterol or who have heart disease and require additional lowering of their LDL cholesterol.

Although analysts on Wall Street had expected Nexletol to be a commercial success, sales of the drug since its approval have been anemic. Between July and September, Esperion recorded just $14 million in net U.S. revenue from Nexletol and a combination pill that pairs it with the generic cholesterol drug ezetimibe.

The slow market launch, which Esperion initially blamed in part on the COVID-19 pandemic, has dragged on the company, which was forced to cut 40% of its staff in October last year. Its market value has steadily eroded and shares are now a fraction of what they were worth when Nexletol was approved.

Without details on the cardiovascular outcomes study’s success, it’s unclear whether the data will be able to restore Esperion’s fortunes.

Michael Yee, an analyst at Jefferies who in the past suggested Nexletol sales could grow into the billions of dollars, said Esperion needs to show cardiovascular risk reduction versus placebo of at least 15%. That kind of benefit would be comparable to what Repatha and a similar drug called Praluent delivered in their respective outcomes trials. But both of those drugs are more potent than Nexletol, delivering larger reductions in LDL cholesterol in clinical testing.

Yee, in a note to clients, wrote that Esperion could submit the data to regulators in support of an expanded drug approval early next year, potentially leading to inclusion of a heart benefit on Nexletol’s labeling in 2024.