Pharma giant Merck & Co. took a major step forward in its pursuit of an oral PCSK9 inhibitor with two phase 3 wins for enlicitide decanoate, a novel treatment for high cholesterol. The results come from trials evaluating the efficacy and safety of enlicitide in patients with heterozygous familial hypercholesterolemia.
The CORALreef HeFH trial showed significant reductions in low-density lipoprotein cholesterol (LDL-C) levels at Week 24, meeting its primary endpoint. Another trial, CORALreef AddOn, hit its key endpoint of reducing LDL-C levels by Week 8 compared to standard non-statin cholesterol medications.
Enlicitide uses a similar mechanism as approved injectable PCSK9 inhibitors but offers an oral alternative, making it more attractive in terms of administration. This win puts Merck ahead of rival AstraZeneca in bringing the first oral PCSK9 inhibitor to market regulators.
Citi analysts described the data as “encouraging,” predicting that enlicitide could be a key player in the hyperlipidemia space if approved by 2027. The news sent Merck’s stock up 2% before markets opened Monday morning.
Source: https://www.fiercebiotech.com/biotech/mercks-leader-oral-pcsk9-inhibitor-race-reduces-cholesterol-pair-phase-3-trials