NGM386 and NGM395
NGM386 and NGM395 are the lead product candidates in our program addressing the NP201 signaling pathway. NP201 is NGM’s code for a human hormone expressed by tissues involved in core metabolic functions, including the liver, and facilitates essential metabolic activities by reducing body weight and normalizing blood glucose. Our research indicates that the hormone’s mechanism of action is a fundamental part of the body’s maintenance of a normal weight set point, and we believe that NP201 is a potential novel and differentiated pathway relative to existing options for the treatment of core metabolic conditions, including obesity, type 2 diabetes and NASH.
We have advanced two engineered variants of NP201 into preclinical development: NGM386, a once-daily formulation and NGM395, a long-acting molecule. We granted Merck a worldwide license to further research, develop and commercialize NGM386, NGM395 and other NP201 agonists, and have an option to participate in the global development and commercialization when a candidate has advanced to Phase 3 trials. Merck is expected to initiate Phase 1 human trials for the NP201 program in 2016, which could potentially provide an early proof of concept for the pathway.