Merck enters agreement with Hanmi for investigational NASH drug

Merck/MSD has reached a licensing agreement with Korea’s Hanmi Pharmaceutical for an investigational GLP-1/glucagon dual receptor agonist for nonalcoholic steatohepatitis (NASH).

The focus of the collaboration is efinopegdutide (formerly known as HM12525A), which has previously been evaluated in a number of phase 1 and phase 2 clinical trials. This includes trials for the treatment of severely obese individuals with and without type 2 diabetes, undertaken as part of a previous licensing agreement forged with Johnson and Johnson.

In 2015,  J&J and Hanmi entered an alliance to develop efinopegdutide to treat diabetes and obesity, with Hanmi receiving an upfront payment of $105m for the drug. However, efinopegdutide failed to demonstrate clinical significance in these indications, and J&J decided not to take the programme forward as a result of the weak data.

As part of the new Merck deal, Hanmi will receive an upfront payment of $10m and is eligible to receive milestone payments of up to $860m, associated with development, regulatory approval and commercialisation of efinopegdutide. In return, Merck will be granted an exclusive license to develop, manufacture and commercialise the drug in the US and globally, although Hanmi will retain an option to commercialise efinopegdutide in Korea.

“Data from phase 2 studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” said Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology, Merck Research Laboratories.

“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,” he added.

The deal with Hanmi builds on Merck’s existing NASH pipeline, which includes a mid-stage candidate, NGM313, licensed from NGM Biopharmaceuticals last year. NGM313 is an antibody targeting the beta-Klotho/FGFR1c receptor complex that could represent a new a completely new drug class for NASH and diabetes. The drug works by activating FGFR1c signalling, a pathway that appears to have a key role in maintaining metabolic balance in the body.

A number of companies are developing treatments for NASH, a condition which is characterised by a build-up of fat and scarring in the liver. As drugmakers race to bring treatments for NASH to market, the therapy area has seen a number of late-stage failures, including Gilead’s ASK1 inhibitor selonsertib and Genfit’s elafibranor.

Intercept Pharmaceuticals is awaiting a US Food and Drug Administration (FDA) review of its obeticholic acid drug Ocaliva in NASH after a number of delays, first in January and then again in May, with the latter due to the ongoing COVID-19 pandemic.

Meanwhile, Zydus Cadila became the first pharma company in the world to win approval for a NASH drug, after scoring authorisation for its drug saroglitazar in India.