FDA Review of Approved Drug, Ubrogepant, Included DILIsym Simulations

FDA Review Document and New Toxicological Sciences Publication Detail Results

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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.

About DILIsym Services, Inc.

DILIsym Services, Inc., was founded in 2015 in Research Triangle Park, North Carolina, and has developed DILIsym and NAFLDsym® QSP software, and is developing IPFsym™ and RENAsym™ QSP software, to provide the pharmaceutical industry with the tools and resources to efficiently develop safe and effective drug therapies. DILIsym and RENAsym are designed to address drug-induced liver injury (DILI) and drug-induced acute kidney injury, respectively. NAFLDsym and IPFsym are designed for target or compound evaluation of therapeutic efficacy in nonalcoholic fatty liver disease (NAFLD or NASH) and idiopathic pulmonary fibrosis (IPF), respectively. Thus, DILIsym and RENAsym may be applied to address drug safety across therapeutic areas, while NAFLDsym and IPFsym may be applied to support the development of efficacious drugs in these therapeutic areas. DILIsym Services makes these tools available to small, mid-size and large pharmaceutical organizations and regulatory agencies through its licensing programs. In addition to performing consulting services using the modeling software, the expert scientific team engages clients from initial program design through data input and “results” interpretation. The company’s mission is to apply its modeling and simulation expertise to support the development of safe and efficacious drug therapies. More information is available on the company’s web page.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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