Title: The Largest Small Molecule: Manufacturing Process for Enlicitide
ABSTRACT:
Atherosclerotic cardiovascular disease is a leading cause of mortality globally. Inhibiting PCSK9, a validated therapeutic target in hypercholesterolemia, has been shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) in patients and improve cardiovascular outcomes. At present, in the absence of an approved orally available PCSK9 inhibitor, there has been limited uptake of the three marketed injectable medicines targeting PCSK9. Enlicitide decanoate (MK-0616) is a novel macrocyclicpeptide that has demonstrated oral bioavailability and significant reductions in LDL-C in Phase 3 studies. This talk will highlight how our team is harnessing the power of biocatalysis to build an efficient, scalable, and sustainable manufacturing process for MK-0616, an unprecedentedly large “small” molecule.