Simulations Plus , Inc., a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that its DILIsym Services (DSS) division has released DILIsym ® version X (DSX) Beta, the latest version of its flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI).
Dr. Paul B. Watkins , chair of the Scientific Advisory Board of the DILI-sim Initiative, remarked: “DILIsym has shown great value in accurately predicting liver safety liabilities of new drug candidates. DSX represents a great advance in that it simplifies the use of the software and greatly increases the speed with which it provides results. This will enable much wider adoption of the software by Pharma, regulators, and academics.”
Dr. Brett Howell , president of the DILIsym Services division, added: “DILIsym is increasingly being used for high impact applications in the safety space. This latest release of DSX, which is the product of very hard work by our software development team, led by our Senior Software Engineer Corey Berry, enhances the speed and user-friendliness of DILIsym forward significantly.”
DILIsym modeling supports key drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to FDA approval. For the past 12 years, the DILIsym Services division has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package.
Substantial updates for DSX include:
- A complete software redesign that includes command line and graphical interface options and server/cloud computing capability (HPGL)
- 4 new exemplar compounds included with varying clinical presentations:
- PF-04895162 ( Generaux 2019 )
- Efavirenz
- Anastrozole
- Tamoxifen
- 2 new SimCohorts that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin)
