By Christy Santhosh
March 30 (Reuters) – Drugmaker Merck said on Monday its oral drug met the main goal of meaningfully reducing bad cholesterol in a late-stage head-to-head trial with other therapies.
Merck’s non-statin cholesterol drug, enlicitide decanoate, was being tested in patients with hypercholesterolemia, which is characterized by elevated levels of LDL (bad) cholesterol in the blood, often leading to plaque buildup in the arteries.
The trial data provides a shot in the arm for the company, which is looking for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade.
The eight-week trial compared enlicitide directly with existing oral non-statin therapies, bempedoic acid and ezetimibe, in patients receiving background statin treatment.
In the head-to-head trial, the drug reduced LDL cholesterol by up to 64.6% from baseline when added to background treatment with a statin.
Additionally, enlicitide reduced LDL-C by 56.7% compared with bempedoic acid, a non-statin oral cholesterol-lowering drug, and by 36.0% compared with ezetimibe, which works by blocking cholesterol absorption in the gut.
Enlicitide reduced LDL-C by 28.1% compared with a combination of the two therapies.
The drug could be one of Merck’s “most underappreciated pipeline assets with peak sales potential of tens of billions of dollars,” Scotiabank analyst Louise Chen said.
Merck’s drug has the U.S. Food and Drug Administration Commissioner’s National Priority Voucher, so approval could come as early as 2026, Chen added.
In September, the drug showed meaningful reductions in LDL cholesterol, compared with placebo during a 24-week trial.
Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol.
Similar treatments in development include AstraZeneca’s oral PCSK9 inhibitor, AZD0780, and Verve Therapeutics’ gene-editing therapy to lower cholesterol.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)
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