Laroprovstat

Bengaluru: Merck's oral drug met the main goal of reducing bad cholesterol in a late-stage trial, it said on Tuesday, marking a second win for the drug since June. 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. Merck's non-statin cholesterol drug, enlicitide decanoate , was being tested in patients with hypercholesterolemia, a condition characterized by elevated levels of LDL (bad) cholesterol in the blood, often leading to plaque buildup in the arteries. The condition affects about 73.5 million Americans, leading to increased risk of heart disease, according to government data. In the 24-week trial, Merck's drug showed meaningful reductions in LDL cholesterol, when compared to placebo. In June, the cholesterol pill succeeded in two late-stage studies when tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels potentially leading to heart attacks and strokes. 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 drug AZD0780 and Verve Therapeutics' gene therapy, which is expected to be used in combination with other drugs. (Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)

Merck’s experimental drug for high cholesterol passed another Phase 3 trial, bringing it closer to potentially becoming the first oral option in a class of medicines called PCSK9 inhibitors. Enlicitide decanoate significantly lowered patients’ “bad cholesterol” at 24 weeks compared to placebo, Merck announced on Tuesday. The CORALreef Lipids study enrolled patients with elevated bad cholesterol, or LDL-C, and a history or increased risk of major atherosclerotic cardiovascular disease events. Patients were being treated with a moderate- or high-intensity statin, or had a statin intolerance. The company has touted enlicitide as a more convenient option compared to injectable PCSK9 drugs currently on the market for high cholesterol, such as Amgen’s Repatha and Sanofi and Regeneron’s Praluent. “If approved, it has the potential to change the way we think about managing LDL levels, giving patients the possibility of a new option to help them meet their treatment goals,” Merck Research Laboratories president Dean Li said in the Tuesday news release. Merck said it would share the results with regulators around the world. More data are expected to be presented at a future conference. In June, Merck announced that enlicitide successfully cut bad cholesterol in two other Phase 3 trials. The company has also fully enrolled a cardiovascular outcomes study with more than 14,500 patients. Meanwhile, AstraZeneca is closing in with a rival candidate called laroprovstat, which is now in Phase 3. The pharma company presented positive Phase 2b data in March.