Applying the QSP Model NAFLDsym® to Predict and Understand NASH Treatments

Authors: Siler SQ
Conference: NASH Summit
Keywords: drug induced liver injury (DILI), lipotoxicity, NASH, non-alcoholic steatohepatitis, qsp, quantitative systems pharmacology, steatosis
Software: DILIsym®, NAFLDsym®
Division: DILIsym Services

Outline

  • NAFLD incidence is growing worldwide with few treatment options
    • Substantial opportunity to improve health for many patients by developing treatments
  • NAFLDsym is a QSP model of NAFLD and NASH
    • v1A focuses on key pathways that contribute to steatosis and lipotoxicity; currently in use
    • Currently developing v2A, which will include inflammation and fibrosis sub-models; available Q4 2018
    • Includes >300 diverse simulated patients in SimPops™
    • NAFLDsym utilizes many key aspects of DILIsym®
  • NAFLDsym can be used to support NAFLD drug development
    • Combines PK, PD, pathophysiology to predict efficacy of novel treatments
    • Flexible framework facilitates addition of new targets as needed
    • Can be used to optimize clinical trial protocols and identify key hypotheses related to mechanistic underpinnings of predicted response to treatment
  • NAFLDsym has been used in collaborative research agreement with Pfizer, Gilead and other companies to inform clinical programs

NASH Summit 2018, April 23-25, 2018, Boston, MA

By Scott Q. Siler