MERCK: Merck Exercises Option for NGM Bio’s Investigational Insulin Sensitizer, NGM313, for the Treatment of NASH and Type 2 Diabetes


Merck issued the following announcement on Jan. 3.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NGM Biopharmaceuticals, Inc. (NGM) today announced that Merck has exercised its option to license NGM313, an investigational monoclonal antibody agonist of the β-Klotho/FGFR1c receptor complex that is currently being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) and type 2 diabetes. This is part of the companies’ broad strategic collaboration to discover, develop and commercialize novel biologic therapeutics announced in 2015.

“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,” said Dr. Joe Miletich, senior vice president, preclinical and early development, Merck Research Laboratories. “Merck is committed to advancing candidates with the potential to have a meaningful impact in the treatment of metabolic diseases, including NGM313 for NASH.”

With the exercise of this one-time option, which was triggered by NGM’s completion of a proof-of-concept clinical study of NGM313, Merck gains exclusive worldwide rights to develop, manufacture and commercialize NGM313, now renamed MK-3655, and related compounds. In connection with the option exercise, NGM received a $20 million payment from Merck. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to participate in up to 50 percent of a global cost and revenue sharing arrangement for MK-3655. If NGM does not exercise its option, NGM is eligible for further payments associated with the progress of MK-3655 development, as well as commercial milestone payments and tiered royalties ranging from low double digit to mid-teen percentage rates on product sales.

“Merck’s decision to exercise its option for NGM313 provides a strong endorsement of NGM’s powerful drug discovery engine and our ability to translate our novel biologic insights in the clinic,” said Dr. David Woodhouse, chief executive officer of NGM. “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. 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.”

In November 2018, NGM presented positive findings from a Phase 1b proof-of-concept clinical trial of NGM313 in obese, insulin resistant subjects with nonalcoholic fatty liver disease (NAFLD) at AASLD’s The Liver Meeting® 2018. In the study, preliminary data indicated that a single dose of NGM313 resulted in a statistically significant reduction in liver fat content (LFC) and improvements in multiple metabolic parameters after five weeks. Based on these data, Merck intends to advance NGM313 into a Phase 2b study to evaluate the effect of NGM313 on liver histology and glucose control in NASH patients with or without diabetes.

Original source can be found here.

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