MSD’s oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor has succeeded in a third Phase III trial in patients with hypercholesterolemia.
In the CORALreef Lipids trial (NCT05952856), once-daily enlicitide decanoate significantly and clinically reduced low-density lipoprotein cholesterol (LDL-C) compared to placebo after 24 weeks of treatment, meeting the primary endpoint.
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Statistically and clinically significant reductions were also seen for enlicitide across all key secondary endpoints, including in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)].
This data marks the third Phase III trial to demonstrate clinically meaningful and statistically significant LDL-C lowering for enlicitide, said Dr Dean Li, president of MSD Research Laboratories.
Li said: “The advent of injectable PCSK9 inhibitors has enabled a new approach to controlling LDL-C and reducing the risk of atherogenic cardiovascular events.
“Enlicitide, designed to deliver antibody-like efficacy, is the first oral macrocyclic peptide PCSK9 inhibitor with clinically meaningful and statistically significant LDL-C lowering in Phase III trials. 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.”
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By GlobalDataMSD plans to share results from the trials of its oral PCSK9 with regulatory authorities worldwide and will present the data at a future scientific congress.
Earlier this year, MSD announced data from two Phase III trials of the therapy, CORALreef HeFH (NCT05952869) and CORALreef AddOn (NCT06450366) trials, which both successfully met their primary and all key secondary endpoints.
Enlicitide is a novel small molecule macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. If approved, enlicitide would be the first oral PCSK9 inhibitor on the market, providing a more favourable administration than current injectable medicines.
GlobalData analysts anticipate a resurgence of lipid-modifying agents following a drop in commercial revenue from 2011. GlobalData pharma analyst Eleni Tokali said the market shrank drastically, from a robust $28bn in 2011 to a low point of $6bn in 2020 due to several patent expiries.
The market is set to rise to $23bn in 2030, GlobalData predicts, primarily driven by Novartis’ Leqvio (inclisiran) and Amgen’s Repatha (evolocumab). Both therapies target PCSK9, similar to enlicitide decanoate.
