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Oct 17, 2021
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QSP modeling leveraging known pathophysiologic characteristics of NASH and FGF19 pathways recapitulated clinical responses to NGM282

Purpose

Nonalcoholic steatohepatitis (NASH) is a growing clinical concern, but currently there is no approved medicine for treatment of NASH. Fibroblast growth factor 19 (FGF19) is an endocrine gastrointestinal hormone, which binds to hepatic FGF receptors (FGFR1 and FGFR4) and impacts multiple pathways relevant to NASH pathophysiology by altering lipid fluxes, lipotoxicity, and reducing hepatic inflammation. NGM282 is an engineered analogue of FGF19, which interacts with FGFR1 and FGFR4. In a clinical trial in patients with biopsy-confirmed NASH, administration of 1 mg or 3 mg NGM282 QD for 12 weeks significantly reduced nonalcoholic fatty liver disease score (NAS) and improved liver fibrosis stage.[1] In the current study, therapeutic effects of NGM282 were predicted using NAFLDsym®, a quantitative systems pharmacology (QSP) modeling platform that has been developed to predict efficacy for treatment modalities aimed towards treating NASH.

By ​Kyunghee Yang, Jeffrey L Woodhead, Grant Generaux, ​Fulya Akpinar Singh, and Scott Q Siler

Presented at American Association of Pharmaceutical Scientists (AAPS) PharmSci 360, October 17-20, 2021

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