Simulations Plus Receives U.S. FDA Renewal for DILIsym Software Licenses

Rhea-AI Summary

Simulations Plus, Inc. (NASDAQ: SLP) announced the renewal of FDA licenses for its DILIsym® software, a leading tool in predicting drug-induced liver injury (DILI). This one-year renewal allows FDA employees continued access to DILIsym across all divisions. Dr. Paul B. Watkins emphasized that this endorsement underscores DILIsym's value in assessing liver safety during drug development, especially after the FDA Modernization Act 2.0 signing. Dr. Brett A. Howell remarked on the growing importance of simulation technologies to enhance drug development efficiency amid rising healthcare costs. DILIsym's predictive modeling aids crucial decisions in drug development by identifying potential DILI risks and guiding go/no-go decisions. Simulations Plus has provided biosimulation solutions for over 25 years, employed by major stakeholders in the pharmaceutical industry.

Positive

• FDA renewed licenses for DILIsym software, indicating regulatory support.
• DILIsym software aids drug developers in predicting DILI risks, enhancing decision-making.
• FDA Modernization Act 2.0 encourages the use of DILIsym in drug development.

Negative

• None.

Provides FDA with software tools to investigate drug-induced liver injury in clinical trials

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. FDA has renewed its licenses to the DILIsym^® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, commented, “The FDA’s renewal of these licenses endorses the value of DILIsym software in both predicting liver safety liabilities and defining the underlying mechanisms, which are critical to evaluating risk. The recent signing of the FDA Modernization Act 2.0 by President Biden, which encourages the FDA to limit animal use in drug development, should be a positive catalyst for greater utilization of DILIsym software in drug development. In my role as Chair of the SAB, I am very excited about the direction of the public-private partnership that is guiding further development of the DILIsym platform that will benefit many key stakeholders.”

Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, added, “Given the effect of rising costs on providing vital healthcare, the use of novel simulation technologies to improve the efficiency of drug development is more critical than ever. An important first step is ensuring that regulatory agencies have the most advanced technology tools to fulfill their essential mission. We are delighted the FDA has opted to renew once again and will continue using DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.”

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 13 years, DILIsym Services, a division of Simulations Plus, 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.

Companies interested in a free trial version of the DILIsym software can request it here.

About Simulations Plus

Serving clients worldwide for more than 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 artificial intelligence (AI)/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.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our ESG Report.

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

Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Financial Profiles

Tamara Gonzalez

310-622-8234

tgonzalez@finprofiles.com

Source: Simulations Plus, Inc.

FAQ

What is the significance of the FDA renewing Simulations Plus' DILIsym software licenses?

The renewal signifies regulatory support for DILIsym, crucial for predicting drug-induced liver injury in clinical trials.

How does DILIsym software impact drug development efficiency?

DILIsym helps in identifying DILI risks, thus guiding critical go/no-go decisions, potentially saving costs on failed trials.

What recent legislation may affect the usage of DILIsym software?

The recent signing of the FDA Modernization Act 2.0 encourages reduced animal use in drug development, potentially increasing DILIsym's utilization.

Who commented on the FDA's renewal of DILIsym software licenses?

Dr. Paul B. Watkins and Dr. Brett A. Howell provided insights on the software's importance and the impact of rising healthcare costs.

How long has Simulations Plus been providing biosimulation solutions?

Simulations Plus has been serving clients worldwide for over 25 years, specializing in drug discovery and regulatory submissions.