NGM Bio Initiates Phase 1 Clinical Trial of NGM313, a Proprietary Antibody with the Potential to Treat Type 2 Diabetes, Obesity and NASH
SOUTH SAN FRANCISCO, Calif., June 8, 2016 /PRNewswire/ – NGM Bio, a privately-held biotechnology company that translates powerful biology into transformative medicines, today reported initiation of a Phase 1 trial of NGM313 in overweight or obese volunteers. NGM313 is an agonistic antibody engineered to selectively activate the beta-klotho (KLB)-FGFR1c receptor complex and promote beneficial metabolic activity. NGM313 was discovered and is being developed by NGM Bio as a potential treatment for type 2 diabetes, obesity and nonalcoholic steatohepatitis (NASH). Under the terms of a collaboration agreement with Merck Sharp and Dohme Corp. (“Merck”) executed in 2015, Merck has an exclusive, one-time option to license NGM313 following completion of a human proof of concept study.
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability and pharmacokinetic profile of NGM313 after single and multiple ascending doses. The study will also measure a variety of biomarkers associated with metabolic regulation. Data from the trial are expected in 2017.
“This first-in-human trial represents a significant step towards establishing the profile of NGM313, which we hope will be an important new medicine for the treatment of metabolic diseases,” noted Alex DePaoli, M.D., Vice President and Chief Medical Officer of NGM Bio. “The identification of this novel therapeutic also highlights the capabilities of NGM Bio's research team, who engineered a potent and highly selective antibody that represents an innovative approach to modulating the activity of this pathway.”
NGM313 is a humanized monoclonal antibody engineered to selectively agonize (or activate) the KLB-FGFR1c receptor complex. KLB-FGFR1c is involved in the regulation of body weight, triglycerides and cholesterol, as well as insulin sensitivity and the uptake of glucose in various tissues. NGM Bio believes that NGM313 has the potential to cause meaningful body weight loss and improved insulin sensitivity via a mechanism that is complementary to existing type 2 diabetes treatments that promote insulin production or secretion.
About NGM Bio
NGM Bio is a research-driven biotechnology company committed to discovering and developing novel biologics for the treatment of life-threatening diseases. NGM Bio's portfolio consists of two programs in clinical testing and more than a dozen additional programs in various stages of preclinical development. Our most advanced compound, NGM282, is a wholly-owned asset that is in multiple Phase 2 trials, including for the treatment of primary sclerosing cholangitis and NASH. NGM Bio has established collaborations with Merck and MedImmune/AstraZeneca. NGM Bio is a privately-held company backed by investments from The Column Group, Merck, Prospect Ventures, Topspin Partners, Rho Ventures, Tichenor Ventures and other leading investors around the world. For more information or to explore career opportunities with us, please visit www.ngmbio.com.
Stern Investor Relations, Inc.