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Message: Re: Esperion
4
Feb 03, 2017 10:48AM

First off, Esperion seems to have suspended their clinical program for their injectable apoAI mimetic ETC-216. ETC-216 is a synthetic HDL molecule that was shown in a Phase 2 clinical trial over 13 years ago to reduced plaque volume. No further clinical trials have been performed on ETC-216 since, to the best of my knowledge.  So yes, Esperion's old drug (ETC-216) that is seemingly no longer being pursued is an injectable that modulated/enhanced HDL activity. Still, Resverlogix's RVX-208 is an oral drug of a completely different target/mechanism of action. As detailed below, the recent activity of Esperion is focused on ETC-1002/bempedoic acid, which is a statin-alternative for LDL-lowering.

Esperion is on the rise today because of yesterday's announcement by Amgen that Amgen's LDL-lowering anti-PCSK9 antibody Repatha (Evolocumab) drug met its primary endpoint for reducing MACE events. There was recent pushback by the FDA against approving new LDL-lowering drugs based on LDL-lowering alone; the FDA wanted renewed proof that the LDL-hypothesis is still valid....that lowering LDL reduces MACE. The Repatha/Fourier trial met its endpoint. Esperion's ETC-1002/bempedoic acid is currently in trials in US and Europe for both LDL-lowering and reducing cardiovascular events. LDL-lowering trials are short; cardiovascular trials are long. The FDA wouldn't guarantee Esperion that it could get approval to market its drug for LDL lowering alone, unlike the European EMA who pretty much gave the green light that if trials are successful that it could be marketed in Europe for LDL-lowering and reduced cardiovascular events. So Esperion is indirectly benefiting from the Repatha/Fourier trial results with the hope that now that the anti-PCSK9-mediated LDL-lowering has shown reduced MACE events that maybe, just maybe, the FDA will revisit their guidance to Esperion on ETC-1002/bempedoic acid and that it could be marketed/approved in US for LDL-lowering prior to the completion of the cardiovascular outcome trials.

 

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Feb 03, 2017 12:41PM
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