Esperion Therapeutics initiates Phase III long-term safety and tolerability study (ETC-1002-040) of bempedoic acid (ETC 1002) in patients with hyperlipidaemia

Esperion Therapeutics announced the start of a global Phase III long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidaemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017.

ETC-1002-040 is a Phase III randomised, multicentre, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 900 patients with hyperlipidaemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study will enrol patients at approximately 125 sites in the US, Canada and the European Union. The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on other lipid and cardiometabolic risk markers, including LDL-C and high-sensitivity C-reactive protein.

This study marks the launch of the Phase III clinical programme – known as Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen (CLEAR) – which will be focused on the development of bempedoic acid for statin-intolerant patients with uncontrolled LDL-C levels.

Comment: Both Repatha (evolocumab) and Praluent (alirocumab) have been FDA and EU approved as PCSK inhibitors to reduce cholesterol. Alnylam and The Medicines Company have ALN PCSsc in Phase II development offering quarterly or bi-yearly dosings. Esperion plans for its product to be taken orally and sees this as an advantage over its competitors.