MSD has reported positive results from the Phase III CORALreef Lipids trial for oral PCSK9 inhibitor enlicitide, demonstrating statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and lipoprotein(a) levels at 24 weeks versus placebo. The cyclic peptide therapy achieved all primary and secondary endpoints in this randomised double-blind study involving high-cholesterol patients with atherosclerotic cardiovascular disease risk or history. Safety profiles showed no clinically meaningful differences between treatment groups.

Enlicitide targets PCSK9 to enhance hepatic clearance of LDL cholesterol, addressing unmet needs in the 70% of patients failing to achieve lipid targets with current therapies. The successful trial completes MSD's Phase III package for regulatory submissions, positioning enlicitide as the first oral alternative to injectable PCSK9 inhibitors.

PharmCube's NextBiopharm® database shows that enlicitide could disrupt a sector of 82 firms developing 89 projects, including 7 already on the market. Click here to request a free trial for NextBiopharm®.