ACC Recommends Approved Drug for Lowering LDL
Source: Joseph Pantginis
August 30, 2022 (Investorideas.com Newswire) This same medicine is currently being evaluated in a global clinical trial from which topline results are expected in Q1/23, noted an H.C. Wainwright & Co. report.
Esperion Therapeutics Inc.'s (ESPR:NASDAQ) Nexletol (bempedoic acid) has been recommended by an American College of Cardiology (ACC) task force as a non-statin, LDL cholesterol-lowing therapy, reported H.C. Wainwright & Co. analyst Joseph Pantginis in an August 26, 2022 research note. The recommendation was published in the online version of the Journal of the American College of Cardiology.
"This recommendation addresses the current gap in care for atherosclerotic cardiovascular disease (ASCVD) patients, particularly in high-risk individuals who cannot reach their LDL cholesterol goals with a statin alone," Pantginis pointed out.
Currently, bempedoic acid is approved in the U.S. and the European Union (EU) as an oral, once-a-day LDL cholesterol-lowering drug for patients with ASCVD or heterozygous familial hypercholesterolemia.
The ACC task force based its recommendation on data from the Phase 3 CLEAR Tranquility and CLEAR Serenity trials. Both showed that bempedoic acid 180 mg daily in patients with statin-associated muscle symptoms but not taking a statin drug lowered their LDL cholesterol level by about 24.5% versus placebo.
"Taken together, we believe the strong clinical evidence, and now expert recommendation further support[s] the potential ability [of] bempedoic acid to reduce cardiovascular risk in patients with statin intolerance," Pantginis commented.
The analyst indicated bempedoic acid is the subject of another trial, CLEAR Outcomes, for which topline results are anticipated in Q1/23, a potential stock moving event. This study involves more than 14,000 patients at 1,200 sites in 32 countries.
This randomized, placebo-controlled study will show whether or not treatment with bempedoic acid reduces the risk of cardiovascular events in patients with physician-documented statin intolerance and elevated LDL cholesterol levels. The primary endpoint is the effect of bempedoic acid on cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and coronary revascularization.
"If positive, CLEAR Outcomes is poised to define bempedoic acid as the go-to therapy for statin-intolerant patients," wrote Pantginis. If positive, "we expect the adoption of bempedoic acid in statin-intolerant patients to be significant and to exceed our current penetration of 0.3% to 3.5% and 4% at peak sales in U.S. and EU, respectively."
Lastly, Pantginis relayed that another trial involving bempedoic acid is in the works. With it, Esperion and Kaiser Permanente plan to evaluate bempedoic acid plus ezetimibe, or Nexlizet, in a high-risk group - patients with a recent acute coronary syndrome event.
"We expect the trial to generate key insights on the efficacy and safety of Nexlizet in a patient population often under-represented in clinical trials," Pantginis added.
H.C. Wainwright & Co. has a Buy rating and a $22 per share price target on Esperion, the stock of which is trading now at around $7.67 per share.
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Disclosures For H.C.Wainwright & Co., Esperion Therapeutics Inc., Aug. 26, 2022
H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Joseph Pantginis, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
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