DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 6A

Software: DILIsym®

DILIsym Services 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 6A 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 v6A 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 this process of developing DILIsym for optimal use through the DILI-sim Initiative as we enter Stage 3 of the consortium over the next three years.”

Dr. Brett Howell, President of DILIsym Services, added, “This new release of DILIsym is the result of many months of intense effort by our talented modeling and simulation team and the support of our member companies. It reflects the priorities of the pharmaceutical liver safety community, as represented by the member companies of the DILI-sim Initiative, and we are excited to make this new product available to the members.”

A sample of the enhancements include:

  • New validation compounds (ambrisentan, sitaxsentan, phenformin, nelfinavir)
  • New simulated population focused on biomarker variability, SimPops™ (v6A-1), with variability in alanine aminotransferase (ALT) parameters
  • New capability for population-level PK data input (for enhanced compatibility with Simulations Plus’ GastroPlus™ and other PBPK programs)
  • Substantial improvements in the PBPK submodel
  • Addition of TNF-?-mediated survival and regeneration for better representation of pleiotropic functionality
  • Updated DILIsym documentation resources, now embedded within the software

Walt Woltosz, chairman and chief executive officer of parent company Simulations Plus, said, “This major release follows our first two months of operations with DILIsym Services, and we are very pleased with the operation and organization of our new division. I like to say that we sell productivity for drug development, and simulation and modeling software provides a tremendous bang for the buck. The DILIsym software provides important information to pharmaceutical companies regarding the potential for drug-induced liver injury from new and existing compounds, and this information synergizes well with GastroPlus and other modeling solutions from Simulations Plus. Project managers can make more informed decisions with respect to taking new compounds forward or switching to alternate compounds based on the insight gained through DILIsym into the likelihood of liver toxicity prior to conducting expensive and time-consuming clinical trials.”