Simulations Plus subsidiary DILIsym was awarded a Fast-Track SBIR grant to fund the development of software for predicting drug-induced kidney injury.

Novel in silico Drug-induced Kidney Injury Model

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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.”

About DILIsym Services, Inc.

DILIsym Services, Inc., was founded in 2015 in Research Triangle Park, North Carolina, and is the leading provider of drug-induced liver injury simulation software and related consulting services to the pharmaceutical industry. The company spun out of the former Hamner Institutes, acquiring all of the intellectual property, software, documentation, and other materials for the DILIsym software. The company’s other products include MITOsym® for simulating in vitro mitochondrial function and a newer product called NAFLDsym® for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options.

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/toxicology 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 to and used in the conduct of research by major pharmaceutical, biotechnology, chemical, consumer goods companies, and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, artificial intelligence, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for molecular property prediction from structure and physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at www.simulations-plus.com.

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