Esperion Therapeutics (ESPR - Free Report) announced that the phase II study evaluating a combination of pipeline candidate, bempedoic acid, and Merck’s (MRK - Free Report) Zetia (ezetimibe) met primary endpoints. The study was evaluating the regimen in patients with both hypercholesterolemia and type II diabetes and receiving diabetes medications but no statin therapy.
Data from the 12-week study showed that treatment with the combination regimen lowered LDL-C (bad cholesterol) levels by 40% compared to placebo. The regimen also reduced high-sensitivity C-reactive protein, a measure of inflammation associated with cardiovascular disease, by 25%. The results showed that the bempedoic acid/Zetia combination led to improvement in multiple cardiovascular disease risk factors.
Shares of Esperion have decreased 20.5% so far this year against the industry’s rise of 5.1%.
We note that regulatory applications seeking approval for bempedoic acid as a monotherapy and in combination with Zetia as a treatment for elevated LDL-C in patients receiving maximally-tolerated statins or Zetia and having inadequate response are under review in the United States and Europe.
A decision from the FDA on the monotherapy regimen is expected by Feb 21, 2020 while a decision on the combination therapy should come by Feb 26, 2020.
Esperion has successfully completed phase III studies evaluating bempedoic acid as a monotherapy and Zetia combination. Data from these studies have shown that the monotherapy regimen achieved addition 18% reduction in LDL-C over levels achieved by maximally tolerated statin. The combination regimen reduced bad cholesterol by 35% compared with 24% for Zetia monotherapy, 20% for bempedoic acid alone and 3% for placebo in similar patients.
These data along with the phase II data showed that bempedoic acid holds potential in patients independent of background statin therapy.
The targeted indications represent a significant opportunity for the company. It is estimated that 78 million people in the United States have high levels of LDL-C along with 73 million people in Europe and 30 million people in Japan. Of these, an estimated 40 million patients in the United States are using statins, which is intolerable in 5% to 20% of this population. A potential approval will likely drive share price of the company higher. The company signed a deal with Daiichi Sankyo Europe in January for commercialization of the candidates in Europe. This deal has already boosted Esperion’s cash resources.
Meanwhile, the company expects to complete enrollment in the CLEAR cardiovascular outcomes study by the end of September. The study is evaluating bempedoic acid for occurrence of major cardiovascular events in statin averse patients with or at high-risk of cardiovascular disease.
Although there is significant opportunity for Esperion’s pipeline candidate, the company’s funds may prove inadequate for successful launch of the drugs. Moreover, Esperion’s candidate will face significant competition from PCSK9 inhibitors — Sanofi (SNY - Free Report) /Regeneron’s (REGN - Free Report) Praluent and Amgen’s Repatha — and several other classes of drugs already marketed for similar indications.
Esperion currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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