=Esperion Therapeutics (ESPR) : late-stage clinical trial results for cholesterol-lowering medication

• Positive top-line results from pivotal Phase 3 long-term safety study of bempedoic acid 
• Reports Q1 (Mar) loss of $1.73 per share, $0.14 worse than the Capital IQ Consensus of ($1.59). 

The phase 3 trial, which enrolled 2,230 patients, met the primary endpoint of safety and tolerability and the key efficacy endpoint, lowering LDL-C an additional 20% after 12 weeks, the company said. LDL-C was also lowered 20% at 24 weeks, and 16% at 52 weeks.

Safety issues for individuals on the therapy, bempedoic acid, happened at a rate of nearly 80%, and serious safety issues were seen at nearly 11%, with the company noting there were "no clinically relevant differences" for those measures between the therapy and the placebo groups.

Fatal adverse events that the company said were "unrelated to study treatment" happened at a nearly 1% rate for patients on bempedoic acid, or 13 patient deaths, relative to a 0.3% rate for patients on the placebo, or two patient deaths, according to an Esperion presentation. Bempedoic acid is intended for high-risk patients with atherosclerotic cardiovascular disease, or artery-clogging fat deposits, who haven't responded well enough to cholesterol-lowering drugs like statins.

Other companies that have or are developing cholesterol-lowering medications include Regeneron Pharmaceuticals (REGN), and Sanofi (SNY), Amgen Inc. (AMGN) and Medicines Company (MDCO) and Regeneron recently announced discounts for its cholesterol-lowering drug, in hopes of boosting sales.