Esperion Therapeutics, Inc. (ESPR) on Tuesday released positive Phase 2b results for ETC-1002, its novel, oral cholesterol lowering therapy. The 12-week study evaluated the efficacy of ETC-1002 in combination with standard statin, and the company plans to move into Phase 3 trials later this year.
ETC-1002 produced 17 and 24 percent reductions in LDL-cholesterol from baseline at doses of 120mg and 180mg (p=.0055 & p<.0001, respectively), compared with 4% for patients taking a stable statin therapy alone. The press release also noted reductions of up to 30 percent in high-sensitivity C-reactive protein (hsCRP). Esperion is initially targeting patients who cannot tolerate higher statin doses in order to achieve optimal LDL-levels.
No increases in muscle-related adverse effects and overall low discontinuation rates were observed in the ECT-1002 study. There was one reported serious adverse event (SAE) in a patient receiving ETC-1002, which was deemed unrelated to drug.
Compare these results to data released this weekend for the injectable PCSK9 inhibitors, alirocumab and evolocumab, from Regeneron (REGN) and Amgen (AMGN), respectively. These drugs in combination with statins reduced LDL-C by 40-70% in many patients, impressive albeit for a twice-monthly injection.
Merck’s (MRK) Zetia (ezetimibe), an oral product often used as an alternative or in combination with statins, produces comparable reductions in LDL (25%) as well as reductions in apolipoprotein B, non high-density lipoprotein cholesterol (non-HDL) and triglycerides. It does not, however, reduce hsCRP, a marker of chronic inflammation. This is an imperfect comparison given the limited scope of the Phase 2b studies as well as the target audience of each drug (Zetia is aimed at patients with hyperlipidemia whereas ETC-1002 targets patients with hypercholesterolemia), however, ECT-1002 continues to carry an attractive profile as an oral competitor to the soon-to-be-approved PCSK9s.
One or more of PropThink’s contributors are long ESPR, REGN, AMGN, or MRK.
