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.


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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. 

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