- Merck & Co. exercised a licensing option with NGM Biopharmaceuticals on a monoclonal antibody being tested to treat nonalcoholic steatohepatitis (NASH) and Type 2 diabetes, the companies announced Thursday.
- NGM will get $20 million in return for giving Merck worldwide rights to develop, manufacture and sell NGM313, which is now renamed MK-3655.
- The medicine has the potential to have "a meaningful impact" in treating metabolic diseases after successfully completing a Phase 1b proof-of-concept study, a Merck executive said in a statement from the two companies.
The deal highlights the appeal of the NASH market for drugmakers. The chronic and life-threatening liver condition doesn't yet have an approved therapy, although four companies — Intercept, Gilead Sciences, Genfit and Allergan — are in late-stage trials.
NGM also has a different NASH medicine, a FGF19 analog known as NGM282 further along in the pipeline in Phase 2 trials. The therapy licensed to Merck is a monoclonal antibody agonist of the β-Klotho/FGFR1c receptor complex and shows potential to be used as a once-monthly injectable insulin sensitizer, the companies said.
For Merck, the new medicine complements its existing franchise in diabetes. The blockbuster Type 2 diabetes treatment Januvia was the New Jersey-based drugmaker's top seller from 2011 to 2017.
The agreement is part of a larger collaboration between Merck and the South San Francisco, California-based biotech that began in 2015.
NGM also has the option to participate in an even split on global cost and revenue sharing for MK-3655, which can be triggered when the first Phase 3 trial begins. If NGM chooses not to exercise that option, it's eligible for more milestone payments and royalties in the future.
Merck is planning a Phase 2b trial to evaluate the therapy's effect on liver histology and glucose control in NASH patients with and without diabetes. About 65% of Type 2 diabetes patients also have NASH, according to the company.