DILIsym Plays Critical Role in Submission to State of California for Common Analgesic Carcinogenicity Risk Assessment

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 the DILIsym liver safety software platform played a key role in public comments submitted to the State of California Office of Environmental Health Hazard Assessment (OEHHA). California’s OEHHA is assessing whether or not the common analgesic acetaminophen (a.k.a., APAP or paracetamol) should be labeled as carcinogenic to humans. DILIsym includes a validated representation of APAP which has been published previously.

The Consumer Healthcare Products Association (CHPA) relied on DILIsym simulations as part of their analysis, and the results were included in the main integrated response document submitted to OEHHA, as well as a separate DILIsym modeling attachment. DILIsym showed that APAP is safe at therapeutic levels and that the potential acute liver toxicity at much higher doses does not cause liver cell stress without overt injury that would lead to cancer. The U.S. Food and Drug Administration also submitted comments to OEHHA that were in agreement with the results submitted by CHPA from DILIsym and other sources.

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. The APAP analysis related to carcinogenicity shows the versatility of the tool in helping with liver safety issues across a wide variety of scenarios and goals. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative), involving scientists from the pharmaceutical industry and academia. Nineteen (19) of the world’s largest pharmaceutical companies have been members of the consortium over the past 10 years.

Dr. Brett Howell, President of DILIsym Services, said: “Acetaminophen is one of the most widely used fever and pain medications in the world. The OEHHA review of this affordable over-the-counter drug for the possible threat of carcinogenicity is an important effort for DILIsym to play a role in through the CHPA submission. DILIsym simulations of the sequence of events leading to liver injury from APAP upon excessively large doses suggest that APAP is not a carcinogenic risk to humans. We are glad to see that the FDA’s public comments to OEHHA agreed with our conclusions. Most importantly, we are excited to continue to see the DILIsym platform be a part of crucial regulatory-related analyses, and look forward to helping many more companies with liver safety issues within the context of regulatory submissions.”

Shawn O’Connor, CEO of Simulations Plus, added: “The use of DILIsym as part of this OEHHA public comments submission for such an important and high-profile case not only shows the versatility of DILIsym, but also shows how the Simulations Plus family of companies continues to be at the forefront of key decisions and investigations within the drug development arena. Our DILIsym Services division’s impact on both the safety and pharmacology aspects of programs via systems modeling is rapidly increasing.”

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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