DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 7A

Keywords: drug-induced liver injury, QSP (quantitative systems pharmacology) modeling program
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

DILIsym Service, Inc., a Simulations Plus company (NASDAQ: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that it has released Version 7A of its flagship QSP (quantitative systems pharmacology) modeling program, DILIsym®.

Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “We are excited to release DILIsym v7A to the members of the DILI-sim Initiative so they can continue using the software to improve the efficiency of the drug development process. The important updates and new features included are the direct result of feedback from our member companies and the oversight of the Scientific Advisory Board. We look forward to continuing to partner with DILI-sim Initiative member companies to further improve its predictive power.”

Dr. Brett Howell, President of DILIsym Services, added, “This latest release of DILIsym is the result of intense effort by our talented modeling and simulation team and the support of our member companies. It includes exciting new tools for improving the usability of the software, and we are thrilled to make version 7A available to the members.”

A sample of the enhancements includes:

  • New validation compounds (tolvaptan, lixvaptan, erythromycin, clarithromycin, azithromycin, solithromycin, telithromycin and BMS-932481)
  • New Optimization interface added allowing complex fitting using genetic algorithms
  • New Clinical Monitoring feature allowing dynamic clinical trials with dose alterations based on specified thresholds
  • New Weight Adjusted Dosing option
  • New Export enhancements providing better information on simulation setup within exported Excel file
  • MATLAB 2017b friendly – faster simulations (delivered in MATLAB 2017b Runtime environment)
  • 2 NEW SimPops
    • Combined ALT biomarker parameter variability with toxicity pathway parameters
    • Mitochondrial biogenesis parameter variability added to SimPops with toxicity pathway parameters
  • NEW feature allowing for creation of Custom SimCohorts from existing SimPops / SimCohorts
  • UPDATED Initial Conditions infrastructure allowing for importing of custom SimPops in compiled version
  • UPDATED Output Table with more clinically important metrics built in
  • DILIsym documentation resources updated for new features

Walt Woltosz, chairman and chief executive officer of parent company Simulations Plus, said: “The DILIsym team has pushed the state-of-the-art forward for the simulation of drug-induced liver injury in the DILIsym platform. Version 7A’s advances provide important new capabilities to enable our customers to better assess the potential for liver damage from new and existing drug compounds. Drug-induced liver injury can result in extreme financial loss when a drug development project has to be canceled, so identifying the potential for it, as well as how serious it might be, needs to be done as early in development as possible. Avoiding a disaster in expensive clinical trials or even post-approval can inform a manager’s decision to switch to an alternate molecule or to identify situations that can be managed to minimize liver injury to an acceptable level.”