On 6 March Merck & Co, presented its Phase II clinical data at the American College of Cardiology Annual Scientific Session, together with the World Congress of Cardiology (ACC.23/WCC) on an investigational, oral cholesterol-lowering drug. At week eight in patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD), MK-0616 significantly reduced low-density lipoprotein (LDL) cholesterol in adults by 41.2% at the lowest dose of 6mg, and by 60.9% at the highest dose of 30mg, with no reports of serious adverse events. The drug is expected to be launched in 2026 and reach $70 million in sales by 2028.

MK-0616 is a macrocyclic peptide designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), resulting in the removal of LDL cholesterol from the bloodstream by inhibiting the interaction of PCSK9 with LDL receptors. This is the same biological mechanism of action as currently approved injectables targeting PCSK9 for the treatment of hypercholesterolemia. MK-0616 reduces the levels of LDL cholesterol with a similar efficacy to injectables such as Amgen’s Repatha (evolocumab), Sanofi/Regeneron’s Praluent (alirocumab), and Novartis’ Leqvio (inclisiran). Injectables inhibiting PCSK9 have been around for a long time but have failed to take off as expected in the dyslipidemia market. This is due to their route of administration and high cost. Merck hopes to do better with a powerful oral daily pill alternative at an affordable price.

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As the global population continues to age and the rate of obesity is increasing, the prevalence of hypercholesterolemia is expected to rise, which could increase the demand for effective cholesterol-lowering medications. High LDL left untreated can increase the risk of ASCVD events such as heart attacks and strokes. Statins are widely used and are first-line therapy to help patients lower their cholesterol levels. However, many patients with hypercholesterolemia are unable to tolerate or do not respond to stains, and therefore MK-0616 offers an effective option to help lower LDL cholesterol levels, hence lowering the risk of ASCVD.

Merck plans to start a Phase III pivotal study for MK-0616 in the second half of 2023. The main advantage of MK-0616 is its oral form, which provides convenience for patients compared to other PCSK9-targeted drugs, like Repatha, Praluent, and Leqvio, that are administered by subcutaneous injection. The results are promising for MK-0616 for the treatment of hypercholesterolemia and, if successful in Phase III clinical trials, MK-0616 could become the first oral PCSK9 inhibitor and a major player in the dyslipidemia space.

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