DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) developing in silico modeling software, resources, and information for assisting the pharmaceutical industry to more efficiently develop safe and effective drug therapies, today announced it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK). The grant, coauthored by Dr. Brett Howell (Principal Investigator) and Dr. Bud Nelson, is entitled “Software for predicting a drug’s potential to cause acute kidney injury.” The total award for this Fast Track SBIR grant is up to $1.7 million over the next 18-24 months. The initial award is for Phase I, at a level of $225,000, with Phase II beginning in January 2019, subject to successful completion of Phase I. Drug-induced kidney injury can be costly, and may require multiple interventions, including hospitalization. The goal of this project is to provide software that can be used in drug development efforts to predict a drug’s potential to cause drug-induced kidney injury, as well as assess and improve the understanding of mechanisms of drug-induced kidney injury.

Brett Howell, Ph.D., president of DILIsym Services, commented: “We are thrilled to see that the NIH supports our mission to help modernize drug development and reduce the time and costs associated with developing new therapies. This large research grant will provide the funding we need to produce the first version of RENAsym™, which will be marketed to the pharmaceutical industry for investigation and screening of possible drug-induced kidney damage. Our team had already begun development of RENAsym, and we will now ramp up to accelerate the process.”

Walt Woltosz, chairman of Simulations Plus, added: “This is a major accomplishment by the DILIsym team, representing the largest federal grant in Simulations Plus’ history. Building on our expertise in drug-induced liver injury and nonalcoholic fatty liver disease, RENAsym will expand our Quantitative Systems Pharmacology (QSP) offerings to include potential damage to the kidney. Identifying the potential for kidney damage as early as possible in a drug development program can avoid costly failures later on in expensive clinical trials. It’s worth noting that RENAsym, like DILIsym® and NAFLDsym®, will require target tissue concentrations generated by physiologically based pharmacokinetics (PBPK) software, and the eventual tight integration of all three products with our industry-leading GastroPlus™ PBPK platform will seamlessly provide the required information to each program.”