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, including 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.
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.
Analysts have noted that the drug has blockbuster potential that expands the PCSK9 market beyond current injectable therapies.
Merck’s drug is designed to lower LDL cholesterol through the same biological mechanism as the currently approved injectable PCSK9 inhibitors, but in a daily pill form.
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)
