Merck, known as MSD outside the United States and Canada, has announced the publication of new research describing the large-scale synthesis of enlicitide decanoate, the company’s investigational oral PCSK9 inhibitor. The findings appear in the latest issue of the peer-reviewed journal Science.
As per the Merck press release, the publication highlights Merck’s efforts to advance scalable manufacturing approaches for complex macrocyclic peptide therapeutics while supporting broader patient access to innovative cardiovascular treatments.
Research Focuses on Scalable Macrocyclic Peptide Production
In the study, Merck scientists detailed a biocatalytic process for assembling enlicitide decanoate using a tailored suite of enzymes. These enzymes selectively catalyse peptide fragment formation, coupling, and macrocyclization during the manufacturing process.
Additionally, the researchers combined the enzymatic process with efficient purification methods using crystallization techniques. As a result, the company successfully developed a scalable production strategy for a product that traditional synthetic methods could not efficiently manufacture.
Merck Highlights Potential of Macrocyclic Peptides
Commenting on the development, Dr. Dean Y. Li, President, Merck Research Laboratories, said macrocyclic peptides could create new opportunities for developing oral therapies for difficult therapeutic targets.
“Macrocyclic peptides have the potential to unlock new opportunities to develop oral treatment options for challenging therapeutic targets and broaden patient access,” he said.
He further added, “The scalable production process for enlicitide described in this publication showcases Merck’s scientific capabilities and underscores our sustained commitment to helping address the global cardiovascular epidemic.”
Sustainable Manufacturing Approach Supports Broader Access
According to the publication, the manufacturing strategy offers a sustainable blueprint for the scalable development of complex macrocyclic peptide therapeutics.
Moreover, the process delivers environmental advantages and manufacturing efficiencies that could help expand patient access to advanced cardiovascular therapies in the future.
Through this research, Merck aims to demonstrate how innovative biocatalytic approaches can support both scientific advancement and sustainable pharmaceutical manufacturing.