Merck bags global rights to NGM NASH drug, plans phase 2b trial

Merck plans to hustle MK-3655 into a phase 2b nonalcoholic steatohepatitis trial. (Merck)

Merck has acquired the exclusive global rights to NGM Biopharmaceuticals’ treatment for nonalcoholic steatohepatitis and Type 2 diabetes. The agreement gives Merck control of a drug designed to reduce liver fat content by selectively activating FGFR1c.

NGM teamed up with Merck in 2015 and took an asset resulting from the collaboration, NGM313, through a phase 1b trial in obese, insulin-resistant nonalcoholic fatty liver disease (NAFLD) patients last year. With the phase 1b linking NGM313 to a statistically significant drop in liver fat content, Merck has paid $20 million to exercise its option on the asset.

The payout gives Merck the exclusive global rights to NGM313, now renamed MK-3655, and related compounds. Merck will make further payments associated with development and commercialization of MK-3655, unless NGM exercises its option to split the costs and profits once it reaches phase 3.

Before that happens, Merck needs to take the monoclonal antibody through midphase development. Merck plans to hustle MK-3655 into a phase 2b trial to assess the effect of the drug on liver histology and glucose control in NASH patients with or without diabetes. 

The stage of development of MK-3655 puts Merck behind a host of companies in the congested race to bring a treatment for NASH to market. Biotechs such as Genfit and Intercept Pharmaceuticals and big companies including Allergan and Gilead Sciences have drugs that are well ahead of MK-3655. The first phase 3 data on these frontrunners are due this year.

Merck’s pitch for a come from behind success rests on the β-Klotho/FGFR1c receptor complex. MK-3655 acts as an agonist of the complex, binding to an epitope of β-Klotho to selectively activate FGFR1c. Notably, NGM thinks the pharmacokinetics of the drug lend themselves to a once-monthly dosing schedule.