Simulations Plus Releases DILIsym X (DSX) Beta with Redesigned Software Infrastructure

Rhea-AI Summary

Simulations Plus (Nasdaq: SLP) has launched the beta version of its DILIsym^® version X (DSX), a significant update to its quantitative systems toxicology software aimed at predicting drug-induced liver injury (DILI). This new version enhances speed and user-friendliness, supporting wider adoption among pharmaceutical companies, regulators, and academics. Key updates include a software redesign, new exemplar compounds, and improved biomarker parameters. The DILIsym modeling approach is crucial for guiding drug development decisions and avoiding costly clinical trial failures.

Positive

• Launch of DILIsym version X (DSX) Beta, enhancing software speed and user-friendliness.
• Inclusion of 4 new exemplar compounds to the software.
• Improved drug development decision-making with predictions on DILI risks.

Negative

• None.

DSX is faster, more user-friendly, and scalable for high-performance computing

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 its DILIsym Services (DSS) division has released DILIsym^® version X (DSX) Beta, the latest version of its flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI).

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, remarked: “DILIsym has shown great value in accurately predicting liver safety liabilities of new drug candidates. DSX represents a great advance in that it simplifies the use of the software and greatly increases the speed with which it provides results. This will enable much wider adoption of the software by Pharma, regulators, and academics.”

Dr. Brett Howell, president of the DILIsym Services division, added: “DILIsym is increasingly being used for high impact applications in the safety space. This latest release of DSX, which is the product of very hard work by our software development team, led by our Senior Software Engineer Corey Berry, enhances the speed and user-friendliness of DILIsym forward significantly.”

DILIsym modeling supports key 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 FDA 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.

Substantial updates for DSX include:

• A complete software redesign that includes command line and graphical interface options and server/cloud computing capability (HPGL)
• 4 new exemplar compounds included with varying clinical presentations:
  • PF-04895162 (Generaux 2019)
  • Efavirenz
  • Anastrozole
  • Tamoxifen
• 2 new SimCohorts that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin)

Contact us to receive a free trial version today!

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230112005049/en/

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 is the latest update from Simulations Plus regarding DILIsym (SLP)?

Simulations Plus announced the release of DILIsym version X (DSX) Beta, improving speed and usability for predicting drug-induced liver injury.

How does DILIsym version X (SLP) impact drug development?

DILIsym version X enables better predictions of liver injury risks, helping guide critical go/no-go decisions in drug development.

What new features are included in DILIsym version X (SLP)?

DILIsym version X includes a complete redesign, command line and graphical interface options, and four new exemplar compounds.

When was DILIsym version X (SLP) released?

The beta version of DILIsym version X was announced in January 2023.