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Simulations Plus to Support Development of Radiation Countermeasure via New QSP Platform (RADAsym) and Pharmacometrics Modeling


QSP and Pharmacometric Strategies Used to Aid Lifesaving Therapy for ARS

Simulations Plus, Inc. (SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it is supporting the drug development program for a lifesaving countermeasure to acute radiation syndrome (ARS) in a partnership with a global pharmaceutical company.

DILIsym Services Inc. (DSS), an SLP company, will spearhead development of RADAsym™. The new QSP (Quantitative Systems Pharmacology) platform will allow for prediction of the effects of radiation on mice, non-human primates, and humans, as well as the impact of interventions on radiation syndrome. Several major biological systems will be included, such as bone marrow, the vasculature, the immune system, the liver, the GI tract, and the lung. The platform will be utilized, along with the expertise of the DILIsym Services scientists, to help garner approval for the treatment under the Animal Rule.

RADAsym will be available for licensing and consulting services in the future, as is currently the case with DILIsym Services’ other QSP offerings like DILIsym® and NAFLDsym®.

Brett Howell, President of DSS, noted, “This is a perfect application of QSP – translation of mechanisms of action from animal to man. Furthermore, we will be able to utilize RADAsym for other radiation scenarios, such as in oncology, as well as other disease areas with overlapping modalities.”

Cognigen, an SLP company, will be supporting the sponsor directly through data curation and exploration as well as pharmacometric modeling activities, and indirectly by partnering with DSS to characterize the pharmacokinetic and pharmacodynamic (PKPD) aspects of this therapy for incorporation in RADAsym.

Jill Fiedler-Kelly, President of Cognigen, added, “The scientific team at Cognigen looks forward to assisting in the development of a comprehensive translational modeling and simulation strategy to support dose selection for this important lifesaving treatment.”

Shawn O’Connor, chief executive officer of Simulations Plus, added: “We are pleased to have been engaged by industry to support this critical development effort. Our expertise across QSP and PKPD techniques and model development positions us uniquely to satisfy the requirements of this endeavor. This engagement also demonstrates our ability to cross-sell the capabilities of our divisions.”

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury and nonalcoholic fatty liver disease. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents. Our software is licensed and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. 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 as filed with the U.S. Securities and Exchange Commission.

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