DILIsym Software Publication Outlines Impact on the CGRP Field for Migraine

DILIsym application contributes to approval of new drugs for migraine treatment

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it has published important simulation results performed with the quantitative systems toxicology model, DILIsym^®, in the esteemed Toxicological Sciences journal (Oxford Academic Press). The results help explain the differentiation in liver safety between small molecule calcitonin gene-related peptide (CGRP) receptor antagonists designed to treat migraine, a debilitating and important unmet medical need. Prior CGRP molecules, such as telcagepant, had failed due to liver injury. DILIsym predicted the safety of next-generation molecules, which have now proven their safety in the clinic. Rimegepant, for example, was approved for the preventative treatment of migraine by the FDA in the Spring of 2021.

Jeffrey Woodhead, Principal Scientist from Simulations Plus, is the first author of the publication entitled “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 failed in the clinic as well as why rimegepant, zavegepant, ubrogepant and atogepant are highly unlikely to face the same issues, providing confidence for drugmakers to move 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 a molecule within a particular class of small molecules has shown liver injury, the entire class will be plagued with this issue. This is not the case, and this work published by Dr. Woodhead and others on the CGRPs clearly shows that DILIsym helps separate safe molecules that have huge positive impacts on patients from unsafe molecules that put volunteers and patients at risk. We are proud to have been a part of several CGRP programs, including rimegepant, ubrogepant, and atogepant, which have all been approved by the FDA after overwhelmingly safe clinical trials. We look forward to helping more companies make the right decisions about progressing versus terminating their candidates.”

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.

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/20220616005373/en/