Merck has licensed NGM Biopharmaceuticals’ NGM313, an investigational monoclonal antibody agonist of the beta-Klotho/fibroblast growth factor receptor 1c that is currently being evaluated for the treatment of nonalcoholic steatohepatitis and diabetes type 2, according to a press release.
“We are pleased with the progress of this collaboration and look forward to future developments with NGM that build upon Merck’s industry-leading position in metabolic diseases,” Joe Miletich, MD, PhD, senior vice president of preclinical and early development at Merck Research Laboratories, said in the release. “Merck is committed to advancing candidates with the potential to have a meaningful impact in the treatment of metabolic diseases, including NGM313 for NASH.”
The license includes the rights to develop, manufacture and commercialize NGM313 — renamed MK-3655 — and related compounds.
NGM presented positive phase 1b data at The Liver Meeting in November 2018. Results showed that NGM313 significantly reduced liver fat content and improved metabolic parameters after 5 weeks in patients with obesity, insulin resistance and nonalcoholic fatty liver disease.
Merck intends to initiate a phase 2b study to evaluate the effects of NGM313 on liver histology and glucose control in patients with NASH with or without diabetes.
“The phase 1b data we presented last year demonstrate NGM313’s potential as a potent, once-monthly insulin sensitizer for the treatment of both NASH and type 2 diabetes,” David Woodhouse, PhD, CEO of NGM, said in the release. “We look forward to Merck’s advancement of this program through clinical development to potentially address the substantial unmet medical need for a single treatment that addresses pathophysiological states common to both diseases.”