NGM Bio Announces Multiple Presentations at AASLD's The Liver Meeting®, Including New NASH Histology Data from the Phase 2 Trial of NGM282 and Topline Phase 1b Data for NGM313

SOUTH SAN FRANCISCO, Calif., Nov. 6, 2018 /PRNewswire/ -- NGM Biopharmaceuticals, Inc., a clinical stage biotechnology company focused on harnessing powerful biology to develop transformative therapeutics for patients, today announced multiple presentations at AASLD's The Liver Meeting® 2018, which will take place in San Francisco from November 9-13, 2018.

Highlights of the meeting will include an oral presentation of histology data from an open-label, dose-finding Phase 2 study of NGM282, an investigational engineered version of the human hormone known as FGF19, in patients with nonalcoholic steatohepatitis (NASH). The adaptive Phase 2 trial, which consists of multiple expansion cohorts, is evaluating the efficacy, safety and tolerability of daily subcutaneous injections of 0.3 mg, 1 mg, 3 mg and 6 mg NGM282 over 12 weeks of treatment in patients with biopsy-confirmed NASH. New data from the 1 mg biopsy cohort will be presented at The Liver Meeting. Data from the 3 mg biopsy cohort were presented at The International Liver Congress in Paris in April 2018, where NGM282 showed a rapid and robust impact on both fibrosis stage and disease activity as measured by the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) at 12 weeks. Additionally, NGM Bio will present a poster evaluating the durability of response to NGM282 by assessing liver fat and biomarkers of NASH at 18 weeks (i.e., 6 weeks following cessation of treatment in the Phase 2 study).

In addition to the NGM282 presentations, NGM Bio will present topline data from a Phase 1b study of NGM313, a proprietary, investigational agonistic antibody that selectively activates the β-Klotho/FGFR1c receptor complex. NGM313 is being evaluated as a potential once-monthly injectable insulin sensitizer for the treatment of NASH and type 2 diabetes.

"We look forward to sharing a range of important data on NGM282 and NGM313 at The Liver Meeting and joining our industry colleagues to learn about the latest scientific and medical advancements to address liver diseases," said Alex DePaoli, M.D., Senior Vice President and Chief Medical Officer. "NASH continues to represent an area of urgent and significant unmet need globally, and we are committed to advancing meaningful medicines that can have a transformative impact by rapidly reversing fibrosis and addressing the multiple pathogenic drivers of disease."

NGM282 Clinical Data Presentations

Publication Number:  0104
Publication Title:  "NGM282 Rapidly Improves NAFLD Activity Score (NAS) and Fibrosis in 12 Weeks in Patients with Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH): Results of a Phase 2 Multi-Center Dose Finding Study"
Session Title:  Parallel 13: Novel Therapeutics for NASH
Presentation Type:  Oral presentation, Parallel Session
Presenter:  Stephen A. Harrison, M.D., Medical Director at Pinnacle Clinical Research, Visiting Professor of Hepatology at University of Oxford, UK; Principal Investigator of NGM282 Phase 2 Study
Session Date and Time: Sunday, November 11, 2018; 2:00 PM
Presentation Time: 2:15 PM

Publication Number: LB-22
Publication Title: "NGM282 Maintains a Durable Off-Treatment Response on Hepatic Steatosis, Inflammation and Fibrogenesis in Patients with Biopsy-Confirmed Nonalcoholic Steatohepatitis: Results of a Multi-Center Phase 2 Dose-Finding Study"
Session Date and Time: Monday, November 12; 8:00 AM – 5:30 PM
Presentation Type: Poster Presentation 
Location: Moscone Center North/South Building, Hall C 

NGM313 Clinical Data Presentation

Publication Number:  LB-21
Publication Title: "NGM313, a Novel Once-Monthly Activator of β-Klotho/FGFR1c, Significantly Reduces Hepatic Steatosis and Key Biomarkers of Nonalcoholic Steatohepatitis: Results of a Randomized, Active-Controlled Clamp Study in Obese Insulin Resistant Patients with NAFLD"
Session Date and Time: Monday, November 12, 2018; 8:00 AM 
Presentation Type: Poster Presentation  
Location: Moscone Center North/South Building, Hall C 

Additional Presentations (Preclinical)

Publication Number: 1308
Publication Title: "NGM282 Demonstrates Antinflammatory and Antifibrotic Activities That Are Independent of Steatosis Reduction in a Farnesoid X Receptor (FXR)-Deficient, Diet-Induced Animal Model of Nonalcoholic Steatohepatitis (NASH)"
Session Date and Time: Saturday, November 10, 2018; 2:00 PM - 7:30 PM
Presentation Type: Poster Presentation
Location: Moscone Center North/South Building, Hall C

Publication Number: 1322
Publication Title: "Fibrosis Regression Observed in Treatment with FGF19 Variants in a Diet Induced Mouse Model of Nonalcoholic Steatohepatitis (NASH) Is Predominantly Mediated By FGFR4 Activity and Independent of Weight Loss or Decreases in Hepatic Steatosis"
Session Date and Time: Saturday, November 10, 2018; 2:00 PM - 7:30 PM
Presentation Type: Poster Presentation
Location: Moscone Center North/South Building, Hall C

About NGM Bio

NGM Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. The company leverages its biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable it to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. NGM aspires to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit www.ngmbio.com for more information.

SOURCE NGM Biopharmaceuticals, Inc.

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