- Esperion Therapeutics Inc. wowed investors on Tuesday with new data that underscored the efficacy of its sole pipeline candidate at lowering bad cholesterol, especially when used with other drugs.
- Patients taking a combination of Esperion's bempedoic acid and ezetimibe, the active ingredient in Merck's Zetia, plus Lipitor (atorvastatin) demonstrated an average 64% drop from baseline in their low density lipoprotein (LDL) cholesterol levels, according to topline Phase 2b results presented Tuesday. Patients on placebo, conversely, experienced a 3% decrease in LDL cholesterol.
- The study's treatment arm also showed a median 48% decrease in high-sensitivity C-reactive protein (hsCRP), whereas the control arm had a median 3% decrease. Research has shown CRP levels correlate with cardiovascular risk, which in turn has prompted cholesterol drugmakers to evaluate them in clinical studies as a way of showing the heart benefits of their products.
Newer cholesterol drugs have largely disappointed investors. The PCSK9 class, which works by breaking down LDL cholesterol, was mostly a market flop as payers and PBMs balked at picking up high-priced offerings like Amgen's Repatha (evolocumab) and Sanofi and Regeneron's Praluent (alirocumab).
Bempedoic acid, however, looks to be riling up optimism. Esperion stock rose more than 13% to $51.10 per share by market open on Aug. 8, and continued to rise in morning trading up to $52.49 apiece.
The drug's strong efficacy both as a monotherapy and in combination with other treatments is surely a main cause for excitement. Last October, early results from a Phase 3 pivotal study showed patients treated with bempedoic acid had a 22% drop in LDL cholesterol and a 35% drop in hsCRP levels after eight weeks compared to placebo. Recently, Esperion also locked down a regulatory pathway for a combination of its drug paired with ezetimibe.
This latest round of data also showed that the drug works wonders when administered with 20 mg of atorvastatin, "the most highly prescribed statin and dose," according to an Esperion second quarter earnings presentation. The regimen didn't trigger any serious adverse events in the study, and at least 90% of patients treated with it had 50% or greater reduction in LDL cholesterol levels and LDL cholesterol levels of less than 70 mg per deciliter.
In addition to the positive results, Esperion announced it had completed enrollment for the mid-stage study, which is set to conclude in December. The company expects to reveal more development plans for the combo plus statin regimen in the first quarter of 2018.