trending Market Intelligence /marketintelligence/en/news-insights/trending/qgirr4gm0ipejpdfyg4i2a2 content esgSubNav
In This List

Esperion's cholesterol drug meets main goal in phase 3 trial

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Esperion's cholesterol drug meets main goal in phase 3 trial

Esperion Therapeutics Inc. said its cholesterol-lowering medicine cleared a phase 3 study designed to establish its safety and effectiveness in patients at a high risk of having a heart attack.

The Ann Arbor, Mich.-based company's drug bempedoic acid 180 mg, which was being evaluated against placebo, met its main goal in the phase 3 trial, named Study 3 or 1002-046, in 345 patients with, or at a high risk of, atherosclerotic cardiovascular disease, or ASCVD having hypercholesterolemia, who were intolerant to statin therapy.

Statin therapy lowers blood cholesterol by reducing its production inside the liver but can also cause serious side effects such as liver failure and death of muscle tissue.

Esperion said the study is the third of five pivotal phase 3 studies expected to be reported in 2018.

At week 24 in the study, patients receiving bempedoic acid had a 26% reduction in their low-density lipoprotein cholesterol, or LDL-C, compared to 2% to those on placebo. LDL-C is also known as bad cholesterol.

The study met its main goal with reduction of 23% in LDL-C at 12 weeks, compared to a 1% reduction in patients receiving the placebo. Patients treated with the medicine also achieved a "significantly greater reduction" of 25% in high-sensitivity C-reactive protein, an important marker of the inflammation associated with cardiovascular disease, while patients on placebo had an increase of 3%.

The company added that a cumulative analysis of the phase 2 and phase 3 results from more than 4,000 patients has demonstrated efficacy, safety and tolerability for bempedoic acid.

Esperion plans to submit new drug applications to the U.S. Food and Drug Administration for bempedoic acid and the bempedoic acid / ezetimibe combination pill for LDL-C-lowering indications by the first quarter of 2019.

In addition, the company is planning to submit marketing authorization applications to the European Medicines Agency by the second quarter of 2019.

Esperion said it expects results from two other trials of the medicine in late August and late September.