Esperion ( NASDAQ: ESPR ) said Nexletol met the main goal of reducing major adverse cardiovascular events (MACE-4) in a phase 3 trial.
The Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial included 14,000 patients and evaluated 180 mg/day Nexletol against placebo.
The study tested whether treatment with bempedoic acid reduces the risk of cardiovascular events in patients with or who are at high risk for cardiovascular disease with documented statin intolerance (inability to tolerate two or more statins, one at a low dose) and elevated LDL-cholesterol levels(also known as 'bad' cholesterol).
"With the announcement of these positive topline results, bempedoic acid becomes the first ATP-citrate lyase inhibitor to demonstrate significant and clinically meaningful outcomes results for patients in whom existing lipid lowering therapies fall short," said Esperion President and CEO Sheldon Koenig.
The company added that bempedoic acid became the first ATP citrate lyase inhibitor and first oral non-statin to meet the MACE-4 primary goal.
Esperion noted that it will present detailed results at a conference in Q1 2023.
Nexletol, along with diet and maximally tolerated statin therapy, is approved to treat adults with heterozygous familial hypercholesterolemia (high cholesterol levels) or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
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Esperion Nexletol helps cut cardiovascular events in phase 3 trial