U.S. FDA Renews Annual DILIsym Software Licenses for 2022

Rhea-AI Summary

Simulations Plus has announced the renewal of its DILIsym software licenses by the FDA, ensuring uninterrupted access for FDA employees across all divisions. This one-year renewal reflects the FDA's continued reliance on DILIsym for evaluating drug-induced liver injury (DILI) risks, which is critical for drug development decisions. The software aids in predicting DILI risks and identifying patient subgroups vulnerable to such injuries, thereby mitigating financial losses from failed clinical trials.

Positive

• FDA renewal of DILIsym software licenses ensures continuous access for FDA employees.
• DILIsym aids in predicting DILI risk, crucial for drug safety assessments.
• Long-term collaboration with FDA enhances credibility in the pharmaceutical industry.

Negative

• None.

FDA Renewal Ensures Access for DILIsym Evaluation of Drug Candidate Submissions

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has renewed its licenses to the DILIsym^® software platform, the DILIsym Services division’s flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued DILIsym software access to FDA employees across all FDA divisions at their discretion through an unlimited licensing package.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, remarked: “DILIsym has been developed over 12 years with input from the pharmaceutical industry and regulators, and the FDA continues to maintain access to the platform. I am aware of many cases of its past and current use for high-profile liver safety projects that are pivotal for the success of large and small pharma companies alike. Interestingly, while there is no formal FDA approval pathway for the use of software like DILIsym in drug development, regulators continue to utilize the software when relevant to the research. By virtue of their continued renewals, the FDA clearly finds DILIsym useful in assessing the liver safety of new drug candidates as they review such cases from sponsors.”

Dr. Scott Q. Siler, Chief Scientific Officer of the DILIsym Services division, added: “We are excited that the FDA has continued access to DILIsym with this license renewal. This will enable them to understand in depth the methods used to develop and utilize DILIsym as well as the resultant simulation results as they need to review simulation results submitted to them.”

DILIsym software results support crucial drug development decisions by predicting potential 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 DILI will not be an insurmountable obstacle to regulatory approval. For the past 12 years, the DILIsym Services division has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.

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About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that 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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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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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Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Hayden IR

Mr. Brian Siegel

346-396-8696

brian@haydenir.com

Source: Simulations Plus, Inc.

FAQ

What does the FDA renewal of DILIsym mean for Simulations Plus (SLP)?

The renewal signifies the FDA's continued reliance on DILIsym for assessing drug-induced liver injury, enhancing the credibility and usability of Simulations Plus' software in drug development.

How long is the FDA renewal period for DILIsym related to Simulations Plus (SLP)?

The FDA has renewed the DILIsym software licenses for a duration of one year.

How does DILIsym help in drug development?

DILIsym predicts potential drug-induced liver injury risks, aiding pharmaceutical companies in making informed go/no-go decisions during drug development.

What is the significance of DILIsym's use by the FDA in relation to Simulations Plus (SLP)?

The FDA's usage of DILIsym highlights its effectiveness and importance in evaluating liver safety, which can enhance the company's market position and attract more clients in the pharmaceutical industry.