FDA Review of Approved Drug, Ubrogepant, Included DILIsym Simulations

DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of modeling and simulation software for pharmaceutical safety and efficacy, today announced that simulations using the DILIsym® software were utilized as part of the U.S. Food and Drug Administration’s (FDA) review of the safety of ubrogepant, which has now been approved for use in the U.S. (UBRELVY™). The utilization of DILIsym results are highlighted in the “Summary of selected (key) nonclinical findings” section of the introduction within the FDA’s nonclinical review document as part of Application Number 211765Orig1s000. The safety assessment of ubrogepant using DILIsym is also summarized in a new publication in Toxicological Sciences which includes authors from multiple organizations.

DILIsym modeling supports key drug development decisions by predicting potential drug-induced liver injury (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 drug-induced liver injury will not be an insurmountable obstacle to FDA approval. Ubrogepant, which was predicted to be safe by DILIsym modeling, is an excellent and important example of this. 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: “Before the pivotal clinical trials of ubrogepant were undertaken, DILIsym modeling predicted the drug’s liver safety relative to the first two drugs in class, each of which failed in clinical trials due to significant liver safety concerns. Ubrogepant is now FDA approved without even a warning of possible liver toxicity, which I believe is a first for a next-in-class drug when the first two in any class had serious liver safety concerns. DILIsym modeling helped support the decision to proceed with clinical development of ubrogepant, and I am confident that the modeling results were part of the weight of evidence that convinced the FDA of ubrogepant’s safety. I am very proud of the role DILIsym is now playing in speeding delivery of safe drugs to the patients who need them.”

Dr. Brett Howell, president of DILIsym Services, added, “Ubrogepant is one of several examples of the prospective use of DILIsym to help de-risk drug development programs. DILIsym Services is excited to continue bringing our DILIsym software-related services, as well as licensing and membership options, to the pharmaceutical industry so that they can help the patients who need new and vital medicines.”

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.