DILIsym Software Release Describes Impact on Migraine CGRP Field

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 the release of important results simulations carried out with the quantitative systems toxicology model, DILIsym®in esteem Toxicological sciences review (Oxford Academic Press). The findings help explain the hepatic safety differentiation between small molecule calcitonin gene-related peptide (CGRP) receptor antagonists designed to treat migraine, a debilitating and significant unmet medical need. Earlier CGRP molecules, such as telcagepant, had failed due to liver injury. DILIsym predicted the safety of next-generation molecules, which have now been clinically proven safe. Rimegepant, for example, was approved for migraine preventative treatment by the FDA in the spring of 2021.

Simulations Plus Principal Scientist Jeffrey Woodhead is the first author of the publication, “Comparing the Liver Safety Profiles of 4 Next-Generation CGRP Receptor Antagonists to the Hepatotoxic CGRP Inhibitor Telcagepant Using Quantitative Systems Toxicology Modeling”. The results highlight why telcagepant has failed in the clinic as well as why rimegepant, zavegepant, ubrogepant and atogepant are highly unlikely to face the same issues, giving drugmakers confidence to go forward with their programs. The study was a collaboration between Simulations Plus and a pharmaceutical partner.

Brett Howell, president of the DILIsym Services division of Simulations Plus, said, “Drug developers and regulators often assume that once one molecule of a particular class of small molecules has shown liver injury, the entire class will struggle with this problem. This is not the case, and this work published by Dr. Woodhead and others on CGRP clearly shows that DILIsym helps separate safe molecules that have huge positive impacts on patients from dangerous molecules that put volunteers and patients at risk. We are proud to have been part of several CGRP programs, including rimegepant, ubrogepant and atogepant, all of which have been approved by the FDA after extremely safe clinical trials. We look forward to helping more companies make the right decisions about whether to advance or terminate their candidates. »

About Simulation Plus

Serving customers 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, physiology-based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and enforced by leading pharmaceutical, biotechnology and regulatory agencies around the world. 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 – Except for historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words such as “believe”, “expect” and “anticipate” mean that these are our best estimates to date, but there can be no guarantee that the results or events expected or anticipated actually occur, so our actual future results could differ materially 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 enhanced versions of our existing software by our customers, the general economic of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical personnel, our ability to identify and complete acquisitions on favorable terms for the Company and a sustainable market. Further information about our risk factors is contained in our quarterly and annual reports and filed with the United States Securities and Exchange Commission.

Jacob L. Thornton