Esperion shares $ESPR got a bounce out of a Phase II update on a triple combination drug using bempedoic acid in reducing LDL. A combination approach adding Zetia and Lipitor to the experimental therapy slashed LDL among subjects with hypercholesterolemia by 64% from baseline, compared to a placebo.
More than 9 out of 10 patients had a greater than 50% reduction in LDL, keeping up with the biotech’s plans to be ready to launch new generic/branded competition that can offer a low-cost approach to controlling LDL.
Shares of Esperion jumped 14% on the news. Those shares have been on a roller coaster ride as analysts speculated about the likelihood the FDA would require an outcomes study ahead of any approval. But last March the biotech said that the FDA would be willing to roll based on LDL data, with cardio work coming after a decision.
Just a few weeks ago the biotech confirmed its pivotal plans, laying out a schedule for a Phase III study that will look at a combination of its drug with Zetia, with a readout in late 2018 and a potential filing in early 2019.
Esperion has a market cap of $1.15 billion, with a steady surge in the price throughout 2017. Shares have more than quadrupled since the beginning of this year.
“Patients in this study experienced nearly a 100 mg/dL drop in their LDL-C levels on the combo plus atorvastatin. These highly positive study results of the combination therapy demonstrate very robust and remarkably consistent LDL-C lowering with what appears to be optimal safety and tolerability,” said Tim M. Mayleben, president and chief executive officer of Esperion. “Next year we intend to initiate additional studies to further explore these complementary oral therapies and provide physicians and payers with an even deeper understanding of how our bempedoic acid-based products may be used in combination with maximally-tolerated statin therapy. Our goal remains to leverage the bempedoic acid franchise to provide physicians with the flexibility to utilize multiple convenient, cost-effective, once-daily, oral therapies to treat the vast majority of patients with elevated LDL-C.”
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