NGM Bio to Present New Data from Phase 1b Study at American Diabetes Assn

NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, today announced that it will present new data from a Phase 1b study of NGM313 at the 79th Scientific Sessions of the American Diabetes Association (ADA) taking place in San Francisco June 7 – 11, 2019.

As part of their ongoing strategic collaboration, NGM and Merck, known as MSD outside the United States and Canada, announced in January 2019 that Merck exercised its option to license NGM313, now renamed MK-3655. Merck intends to advance MK-3655 into a Phase 2b study to evaluate the effect of MK-3655 on liver histology and glucose control in NASH patients with or without diabetes. NGM313 (MK-3655) is an investigational agonistic antibody that selectively activates the β-Klotho/FGFR1c receptor complex. The Phase 1b randomized, open-label, active-controlled parallel group study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of NGM313 in obese, insulin resistant subjects with non-alcoholic fatty liver disease (NAFLD). NGM presented data from the Phase 1b study at the European Association for the Study of the Liver’s (EASL) The International Liver Congress™ (ILC) in April 2019 and the AASLD’s The Liver Meeting® in November 2018.

The new data to be presented at a late breaker poster presentation at the ADA meeting include the evaluation of whole-body insulin sensitivity of a single dose of NGM313 compared to daily dosing of pioglitazone (45 mg), as determined by a two-step hyperinsulinemic, euglycemic clamp.

As previously presented, the Phase 1b data demonstrated that a single dose of NGM313 resulted in a statistically significant reduction in liver fat content, and improvements in multiple metabolic parameters, including improved insulin sensitivity, reduced HbA1c and fasting glucose levels, lowered triglycerides and LDL-C, and raised levels of HDL-C. NGM313 was well-tolerated, with no serious adverse events. All adverse events observed during the course of the study were deemed mild, with increased appetite and injection site reactions being the only adverse events reported in at least 10% of the NGM313-treated subjects (n=17).

https://www.globenewswire.com/news-release/2019/06/05/1864489/0/en/NGM-Bio-to-Present-New-Data-from-Phase-1b-Study-of-NGM313-at-79th-Scientific-Sessions-of-the-American-Diabetes-Association.html