Merck licences NASH drug efinopegdutide from Hanmi

Merck (MSD) has signed an exclusive licensing agreement with Hanmi Pharmaceutical to develop, manufacture and commercialise efinopegdutide (formerly HM12525A) to treat nonalcoholic steatohepatitis (NASH).

Developed by Korea-based Hanmi, efinopegdutide is a GLP-1 / glucagon receptor dual agonist. The drug candidate activates the GLP-1, as well as glucagon receptors.

The drug’s safety and efficacy have been assessed in various Phase I and Phase II clinical studies, including severely obese individuals with and without type 2 diabetes.

Merck clinical research, diabetes and endocrinology associate vice-president Dr Sam Engel said: “Data from Phase II studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH.

“We continue to build on our proud legacy of developing meaningful medicines for the treatment of metabolic diseases and look forward to advancing this candidate.”

As part the deal, Merck will receive an exclusive licence for the development, manufacture and commercialisation of the drug worldwide, including the US.

Hanmi holds an option to commercialise efinopegdutide in Korea. The company will receive an upfront payment of $10m from Merck.

It is also eligible for up to $860 million in development, regulatory approval and commercialisation milestones, along with sales royalties on approved product.

Hanmi Pharmaceutical CEO and president Dr Se Chang Kwon said: “This licensing agreement supports Hanmi’s goals of developing and providing innovative therapies to the patients who need them.

“We believe that Merck’s strong scientific expertise in metabolic diseases makes it well-positioned to advance this candidate forward and maximize its potential for patients around the world.”

Last month, Merck collaborated with contract research services company IRBM for the identification and development of new peptide therapeutics that can target various strains of coronavirus, including SARS-CoV-2.

Merck joined the Covid-19 research and development (R&D) race in May with separate agreements with Themis, IAVI and Ridgeback Biotherapeutics.