Esperion Therapeutics, Inc. ESPR received positive feedback from the FDA for initiation of a phase III bridging study, evaluating the combination of bempedoic acid (180 mg) and Merck & Co., Inc.’s MRK Zetia (ezetimibe) (10 mg) for an LDL-C or “bad cholesterol” lowering indication.
Esperion is evaluating bempedoic acid as monotherapy in an ongoing phase III study for an LDL-C lowering indication. The bridging study, on initiation, will be conducted alongside the ongoing study and will support approval of once-daily, oral combination pill.
Esperion’s year-to-date share price movement shows that the company has significantly outperformed the Zacks classified
Medical - Drugs industry. Specifically, the stock surged 249.3% during this period, while the industry increased 10.1%.
The bridging study will evaluate the combination pill in patients with hypercholesterolemia and with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients. The primary endpoint of the study was to evaluate the efficacy and safety of the oral administration of the combination therapy in adequately controlling the LDL-C.
Esperion expects to finalize the phase III protocol and initiate the study in the fourth quarter of 2017 with top-line data anticipated by the end of 2018. A previously completed phase II study evaluating the combination therapy demonstrated a 48% reduction of LDL-C.
The company also plans to file for regulatory approvals in the U.S. and EU for both the monotherapy and combination pill by the first half of 2019.
The two therapies strengthen Esperion’s portfolio with two separate, convenient and cost-effective non-statin therapies, which can be administered orally for controlling LDL-C. Moreover, the combination pill has potential to address far more patients than bempedoic acid alone.
Per the press release, approximately 150 million people have elevated LDL-C in the U.S. and Europe. Of these, an estimated 40 million patients in the U.S. are using statins, which is intolerable in 5% to 20% of this population. The successful completion of the studies will be a positive for the company as it will bring the therapies closer to approval.
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals, Inc. (
REGN Quick Quote REGN - Free Report) and Enzo Biochem, Inc. ENZ. Regeneron sports a Zacks Rank #1 (Strong Buy) while Enzo Biochem carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Regeneron’s earnings estimates moved up from $10.17 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters, with an average beat of 0.45%. Its share price is up 36.8% so far this year.
Enzo Biochem’s loss estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company came up with positive earnings surprises each of the last four quarters, with an average beat of 55.83%. Its shares are up 61.4% so far this year.
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