Esperion Therapeutics (ESPR) just announced a pooled efficacy analysis from the four Phase III clinical studies of NEXLETOL, an oral, once-daily LDL-cholesterol lowering medicine, notes John McCamant, biotech expert and editor of The Medical Technology Stock Letter.
The analysis was published in the Journal of the American Medical Association Cardiology. JAMA is one of the world’s premiere medical journals and publication in this peer reviewed publication is a significant recognition.
The four Phase III clinical studies evaluated the efficacy and safety of NEXLETOL versus placebo in 3,623 patients with hypercholesterolemia while receiving stable lipid-lowering therapy and at high cardiovascular risk or with hypercholesterolemia and statin intolerance.
The publication highlighted that NEXLETOL added to maximally tolerated statins, including moderate- or high- intensity or no background statin demonstrated significant additional LDL-C lowering levels versus placebo.
In patients on background statin therapy, NEXLETOL lowered LDL-cholesterol (LDL-C) by a mean of 18% compared to placebo. In statin intolerant patients, NEXLETOL lowered LDL-C by a mean of 24% compared to placebo.
Furthermore, decreases in non-HDL-C, total cholesterol, Apo B and hsCRP were greater with NEXLETOL versus placebo. Finally, overall and common adverse events occurred at similar rates in patients treated with NEXLETOL and placebo.
In our view, NEXLETOL is underappreciated by Wall Street as is the need and market opportunity to lower LDL in patients who are intolerant or underserved by statins. ESPR is a potential takeover target as it fits all the usual characteristics including a fully de-risked cardio pill that is FDA approved.
Additionally, while the company has signed very good partnerships for Europe and Japan, importantly ESPR has retained U.S. rights that make it very attractive as a takeover candidate. Buy under $75.
