Merck extends research agreement for NASH drug candidate

The collaboration between Merck, known as MSD outside of North America, and NGM Biopharmaceuticals began in February 2015. The two companies entered an agreement to focus on discovering, developing, and commercializing biologic therapeutics.

Per the original agreement, Merck had the option to extend the initial five-year research and early development phase of the collaboration for an additional two-year period. Merck has exercised its option to extend.

During the two-year extension period, Merck will continue to fund NGM’s R&D efforts. However, Merck will not pay the $20m (€17.6m) extension fee to NGM but instead will make additional payments totaling $20m in support of NGM’s R&D activities during 2021 and 2022.

In January 2019, Merck exercised its option to license NGM313, now known as MK-3655, an investigational monoclonal antibody (mAb) agonist discovered by NGM for the treatment of nonalcoholic steatohepatitis (NASH).

Merck will advance MK-3655 into a Phase IIb study to evaluate the effect of the mAb on liver histology and glucose control NASH patients with or without diabetes.

Terminates license to obesity drug candidate ​

As part of the original agreement, Merck received an exclusive license to NGM’s growth differentiation factor 15 (GDF15) analogs. At the time of the extension, Merck announced that it will terminate its license to NGM’s GDF15 receptor agonist program developed for the treatment of obesity.

The termination of this license occurred after preliminary data from a study of NGM386, a GDF15 agonist receptor, did not result in body weight loss relative to placebo.

Upon license termination, NGM will gain exclusive license to the GDF15 receptor agonist program, including further development and commercialization of potential products.

Merck has an additional option it can exercise in 2021 to extend the research phase for a further two years.