Esperion Therapeutics, Inc. (ESPR - Free Report) announced positive data from a phase III study (1002-053) evaluating a combination regimen of bempedoic acid and Merck’s (MRK - Free Report) Zetia (ezetimibe) for lowering LDL-C (bad cholesterol).
Shares of the company rallied 4.8% following the news on Aug 27. However, the company’s shares are down 21.9% so far this year against industry’s gain of 2.5%.
The phase III 1002-053 study evaluated a combination of 180 mg of bempedoic acid and 10 mg of Zetia in patients with atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia or patients with multiple risk factors for ASCVD receiving maximally tolerated statins compared to bempedoic acid, ezetimibe or placebo over a period of 12 weeks.
Data from the study showed that the combination regimen reduced bad cholesterol by 35% compared to 24% for Zetia (20mg), 20% for bempedoic acid (180mg) and 3% for placebo in patients receiving maximally tolerated statins. Moreover, treatment with the combination regimen led to 32% mean reduction in bad cholesterol in intent to treat patients compared to 21%, 18% and 3% for Zetia, bempedoic acid and placebo, respectively.
The regimen was also superior in reducing inflammation associated with cardiovascular disease in all patients and reducing bad cholesterol in statin intolerant patients. The safety and tolerability of the combination was similar to Zetia alone.
The company also evaluated bempedoic acid as monotherapy in ASCVD patients and successfully completed three pivotal studies early this year. The company is currently evaluating bempedoic acid in another phase III study, 1002-047. Data from the study is expected in October. The company expects to file a new drug application to the FDA in the first quarter of 2019. A regulatory application is expected to be filed in Europe in the second quarter of 2019.
With no approved product in its portfolio, a potential approval to the combination regimen will be a significant boost for the company. However, the market is competitive with the availability of several branded as well generic drugs for lowering bad cholesterol.
Zacks Rank & Stocks to Consider
Esperion currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the same space are Endo International plc (ENDP - Free Report) and BioSpecifics Technologies Corp (BSTC - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo’s earnings per share estimates have increased from $2.39 to $2.60 for 2018 and from $2.54 to $2.69 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 29.11%. The stock has rallied 107.9% so far this year.
BioSpecifics’ earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 15.1% so far this year.
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