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First Approved Cancer Treatment for TGCT Included DILIsym Simulations in FDA Review

·5-min read

FDA Review Cites DILIsym Results as Part of Turalio® Submission

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 their DILIsym® software were noted in a U.S. Food and Drug Administration (FDA) review of the New Drug Application for Pexidartinib (Turalio®, marketed by Daiichi Sankyo, Inc.), which was subsequently approved as the first systemic therapy for treatment of symptomatic tenosynovial giant cell tumor (TGCT). The FDA review also included the general comment by the FDA that DILIsym is helpful for hepatocellular (liver cell) injury. The Turalio® submission is the latest example of how results from the DILIsym software can be valuable in FDA interactions by contributing to safety predictions and safety management strategies.

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. Pexidartinib is a good example of the utility of DILIsym to help with safety evaluation and management, as well as benefit-risk analysis. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative) involving scientists from the pharmaceutical industry and academia.

Dr. Paul Watkins, the Director of the Institute for Drug Safety Sciences at University of North Carolina and chair of the DILI-sim Scientific Advisory Board, said: "With DILIsym, regulators and drug developers alike can better assess safety risks to patients and thereby speed delivery of important new treatments, like pexidartinib, to the patients who need them. I continue to be amazed at the power of DILIsym and the positive impact it is having on drug development programs."

Dr. Scott Siler, Chief Scientific Officer of DILIsym Services, added: "It gives me great pride to have been involved in the Pexidartinib work, a therapy that can save the lives of patients. Our DILIsym software, now coupled with our new kidney injury software in development, RENAsym, comprises the best QST solutions available on the market. At the end of the day, our work is about the patients who need these important medicines in oncology but also many other therapeutic areas. We are glad to see our tools continue to show up in regulatory reviews."

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 the premier developer 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 #1-ranked, intuitive software to bridge data mining and compound library screening with QSAR models, PBPK/TK modeling and simulation in animals and humans following administration around the body, and quantitative systems pharmacology/toxicology approaches. Our technology is now licensed and used 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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View source version on businesswire.com: https://www.businesswire.com/news/home/20201027005460/en/

Contacts

Simulations Plus Investor Relations
Ms. Renee Bouche
661-723-7723
renee@simulations-plus.com

Hayden IR
Mr. Cameron Donahue
651-653-1854
slp@haydenir.com