2023-03-06 06:28:05 ET
Esperion ( NASDAQ: ESPR ) reported detailed results from a phase 3 trial showing that Nexletol reduced risk of major adverse cardiovascular events (MACE-4).
The company had previously reported data from the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes study in December 2022.
On March 4 the company said full results from the trial were presented at the American College of Cardiology’s Annual Scientific Session & Expo and the World Congress of Cardiology. The data was also published in the New England Journal of Medicine .
The study included 14,000 patients with or at risk for cardiovascular disease who were unable to maximize or tolerate a statin.
Esperion said data showed that Nexletol reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and cut the risk of heart attack and coronary revascularization by 23% and 19%, respectively, compared to placebo.
The proportions of patients having adverse events and serious adverse events were similar between the drug group and placebo group, the company added.
Esperion noted that bempedoic acid (contained in Nexleol and Nexlizet (bempedoic acid and ezetimibe) tablets) now becomes the first LDL-C lowering therapy since statins proven to lower hard ischemic events, not only in people with ASCVD (Atherosclerotic cardiovascular disease) but also in the large number of primary prevention patients for whom there are limited treatments.
LDL-C is also known as 'bad' cholesterol.
Esperion thinks that it remains on track to submit regulatory filings in the U.S. and EU in H1 2023.
"Based upon the strength of the data and the clinical significance they represent, we will be filing with the FDA and EMA by June 2023 and anticipate receipt of expanded CV risk reduction labels in 1H 2024 that will more than double the addressable treatment population for NEXLETOL and NEXLIZET," said Esperion President and CEO Sheldon Koenig.
Nexletol and Nexlizet are approved, as adjuncts to diet and maximally tolerated statin therapy, to treat adults with heterozygous familial hypercholesterolemia or established ASCVD who require additional lowering of LDL-C, according to the company.
Esperion said it expects full-year 2023 operating expenses to be about $225M to $245M, including $25M in non-cash expense related to stock-compensation.
Based on the data from the CLEAR trial, the company believes it would be entitled to receive $300M in partner milestone payments after inclusion of certain cardiovascular risk reduction data in the EU label, for which payment is tied to the magnitude of the risk percentage reduction included in the label, among other things.
In addition, ranges between $200M and $300M and up to $140M in partner milestone after achieving other regulatory milestones, including inclusion of certain cardiovascular risk reduction data in the U.S. label, the company noted.
ESPR -21.29% to $4.99 premarket March 6
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Esperion stock slumps ~20% amid Nexletol data showing reduced risk of heart events