Esperion (ESPR) is a de-risked biotech company in the cardiovascular sector with its lead drug, bempedoic acid (BA) — branded NEXLETOL — already FDA approved to reduce LDL cholesterol, explains Jay Silverman, an analyst with The Medical Technology Stock Letter.
It is a safe and effective alternative to statins and reduces LDL in patients on its own and in those that are statin-intolerant, an enormous market that comprises about 10% of all statin-eligible patients (roughly 20 million people worldwide).
In December, ESPR delivered positive, statistically significant top-line clinical data (at least a 15% improvement in MACE-4) from it’s flagship Phase IV study — Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen — the CLEAR Outcomes trial.
The company announced that the trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 (Major Averse Cardiovascular Events) in patients treated with 180 mg/day NEXLETOL compared to placebo.
The company will file for an expanded FDA shortly that will lead to a greatly expanded label (plus widespread insurance coverage) to include these great lifesaving results. Importantly, the CLEAR comprehensive trial data will be presented at the American College of Cardiology (ACC) Annual Scientific Sessions March 4, 2023.
CLEAR Cardiovascular Outcomes Trial CLEAR Outcomes is a Phase 3, event-driven, randomized, multi-center, double-blind, placebo-controlled trial designed to evaluate whether treatment with bempedoic acid (BA) reduces the risk of cardiovascular events (death, heart attack or stroke) in patients with or who are at high risk for cardiovascular disease with documented statin intolerance and elevated LDL-cholesterol levels.
The study included over 14,000 patients at over 1,200 sites in 32 countries. The CLEAT CVOT trial positive results are a watershed de-risking event for Esperion.
The American College of Cardiology conference in March will be a very important meeting as the company now has a very attractive de-risked drug/drug combo that provides a significant LDL lowering/death benefit that is a wholly owned asset that is un-partnered in the U.S.
Having a CVOT label will lead to significantly higher sales potentials and potential partners can either offer attractive royalties or just buy the company out right in what we believe could end up being a near-term bidding war. ESPR is a "buy" under $10 with a target price of $25.