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06.11.2018 23:36
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DILIsym Services, an SLP Company, Launches Consortium for Drug-Related Kidney Injury

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DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety, today announced that it will initiate a quantitative systems toxicology (QST) consortium aimed at addressing the problem of drug-induced kidney injury, the third leading cause for clinical and late stage drug attrition in pharmaceutical development.

The RENAsym Consortium will unite the world’s leading biopharmaceutical companies within a pre-competitive arena to collaborate, share ideas, and guide the development of a novel QST platform for predicting and understanding drug-induced kidney injury, RENAsym™. This new consortium is patterned after DILIsym Services’ highly successful DILI-sim Initiative, which has developed tools to predict and understand drug-induced liver injury. RENAsym will utilize the PBPK module from GastroPlus™, the industry-leading PBPK modeling software, and eventually be offered as a module integrated into the GastroPlus™ platform (as well as in a standalone format).

Drug-induced kidney injury at its worst is deadly, and in less severe cases requires multiple interventions, including hospitalization. Presently, drug developers and physicians have inadequate tools to predict kidney risk. RENAsym will provide a new state-of-the-art QST tool that will help solve this problem.

Dr. Paul Watkins, who will chair the RENAsym Consortium Scientific Advisory Board (SAB), said: "Kidney toxicity remains a major adverse event frustrating the development of new drugs. Given the tremendous success of the DILIsym® software in predicting liver injury due to drugs, many stakeholders urged the team to take on kidney toxicity and we are delighted to see this happening. The Scientific Advisory Board includes the leading scientists in this field and we are all very excited to have them on board.”

Dr. Zheng Dong, Regents’ Professor and Leon H. Charbonnier endowed Chair at the Medical College of Georgia of Augusta University and the Charlie Norwood VA Medical Center, and SAB member, said: "Acute kidney injury (AKI) is a major kidney disease that is associated with nearly 2 million deaths each year around the world. It is mainly caused by sepsis, renal ischemia/reperfusion, and exposure to nephrotoxins. Early detection or prediction of AKI would provide the much-needed time-window for treatment. By incorporating the data from cells and bridging animals to humans, RENAsym will be a computational tool that will be instrumental in predicting drug-induced AKI.”

Dr. K. Melissa Hallow, a Professor of Engineering from the University of Georgia and also an SAB member, stated: "Mathematical modeling of drug-induced kidney injury has the potential to help us understand injury mechanisms, improve utilization and interpretation of injury biomarkers, and better predict likelihood of renal injury, resulting in improved drug development and patient protection. DILIsym Services has put together a fantastic and experienced team to address and tackle this important work.”

The DILIsym software platform has now been utilized by drug developers in many drug development interactions with regulators, and RENAsym will fill this gap in the renal space. Funding for development of the initial version of RENAsym has already been procured via the NIH NIDDK SBIR small business grant process. The RENAsym Consortium will serve as a discussion forum and collaboration facilitator to ensure that the first version of the software released addresses the key needs of the biopharmaceutical industry.

Dr. Brett Howell, president of DILIsym Services, added: "Increased pressure is being put on the developers of new therapeutics to reduce costs while also delivering safer and more effective products. We are excited about the development of RENAsym™, as it will be an effective modeling and simulation tool for reducing the risk for the most important group of individuals in the process: the patients; it will also impact the bottom line for drug developers.”

Shawn O’Connor, CEO of Simulations Plus, concluded: "The DILIsym team has established itself as the leader in QST software and services. Our expansion into drug induced kidney injury with RENAsym leverages this expertise and experience, and the formation of this consortium will provide invaluable input to guide us successfully to an impactful outcome. With substantial funding from the previously announced NIH NIDDK SBIR grant, we are pleased with this addition to our software and services product offerings.”

Contact us to get information on how you can join RENAsym today!

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 DILIsym for predicting drug-induced liver injury, MITOsym® for simulating in vitro mitochondrial function, and NAFLDsym® for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options. More information is available on the company’s Web site at www.DILIsymServices.com.

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. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at www.simulations-plus.com.

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.

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