U.S. FDA Renews Annual DILIsym Software Licenses

Software: DILIsym®
Division: DILIsym Services

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 the U.S. Food and Drug Administration (FDA) has again renewed its multi-seat license for the company’s leading quantitative systems toxicology (QST) modeling software, DILIsym®. The renewal continues to provide DILIsym software access to FDA employees across all FDA divisions at the FDA’s discretion.

DILIsym supports key management decisions by providing information about potential drug-induced liver injury (DILI) risk in upcoming clinical studies and/or post-marketing situations, as well as mechanistic rationale for the underlying biochemical events that could cause liver toxicity. The information from such studies serves to guide go/no-go decisions on major projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that drug-induced liver injury will not be an insurmountable obstacle to establishing the safety of a new compound or dose. A new therapeutic illustrates one such example where a potential blockbuster drug recently approved by the FDA, ubrogepant, was analyzed by DILIsym utilizing SimPops. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative) that involves scientists from the pharmaceutical industry and academia.

Dr. Paul Watkins, founder of the DILI-sim Initiative and chair of the DILI-sim Scientific Advisory Board, said: “Over the last year, DILIsym software has been used increasingly across the Pharma industry to assess the liver safety of new drug candidates, and the modeling results have frequently been shared with regulators. For example, DILIsym modeling predicted the liver safety of ubrogepant relative to the first two drugs in class which failed in clinical trials due to liver safety concerns. The modeling results were part of the weight of evidence supporting approval of ubrogepant. I am pleased to see that the FDA continues to see value in maintaining access to this software.”

Dr. Brett Howell, president of DILIsym Services, also chimed in: “Our pharmaceutical partners continue to see the value of DILIsym for predicting and understanding their liver injury issues. We are glad the FDA does as well, and we look forward to continuing to work with them to ensure they have access to our tools as they conduct their important work of reviewing new drug applications.”

Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.