Simulations Plus and University of Bath Awarded New FDA Grant

LLANCASTER, CA, November 15, 2022 - Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with the University of Bath’s Department of Life Sciences, it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA) to advance state-of-the-art, physiologically-based biopharmaceutics (PBBM)/pharmacokinetics (PBPK) modeling approaches that can inform regulatory decisions on innovator and generic products for locally acting drugs in the gastrointestinal (GI) tract.

For this award, Dr. Nikoletta Fotaki, Professor in Pharmaceutics, her collaborators (Dr. Bernardo Castro Dominguez, Assistant Professor, Department of Chemical Engineering) and her lab at the University of Bath will generate in vitro data from different systems for selected commercial formulations, including conditions simulating healthy, ulcerative colitis (UC), and Crohn’s disease (CD) GI environments, to assess drug release and characterize the critical quality attributes (CQAs) of the marketed products to generate and evaluate formulation variants. The scientific team at Simulations Plus will apply these data sets, along with additional pathophysiology information for UC and CD populations, to enhance and validate the Advanced Compartmental Absorption and Transit (ACAT™) model within the GastroPlus® platform and determine the impact of changes to CQAs and physiological variables on local and systemic exposure in patient groups. The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence for locally acting GI products.

Dr. Haiying Zhou, Sr. Director, Simulation Technologies at Simulations Plus and co-Principal Investigator for this project, said: “The story of GastroPlus started in 1998, and for nearly 25 years it has been, time and time again, independently verified as the preeminent software for predicting oral drug absorption for pharmaceuticals and chemicals alike. This new collaboration with Dr. Fotaki, her team, and the FDA will look to build upon our foundation to improve the accuracy of drug concentrations predicted locally within gut tissue and outline novel strategies for applying in vitro systems and in silico models to lower regulatory burden and minimize the need for animal and human studies as new formulation approaches are evaluated for addressing GI diseases.”

“Thanks to this FDA-funded partnership with Simulations Plus, the future is coming much quicker than we predicted, and this project will be a great way for both industry and academia to make that leap from research into real life applications, with potential benefits of tangible patient outcomes,” said Dr. Fotaki. “Our goal is to allow realization of new models that will bridge the gap between in vitro and in vivo data, and the final framework and best practices developed under this contract will be meaningful for both the FDA as well as the end users in the companies that develop therapies for this disease space.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007660-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.