DILIsym Services Inc. Initiates Development of IPFsym

Business Wire 14-Jan-2019 8:30 AM

New idiopathic pulmonary fibrosis QSP platform to enable more efficient drug development

DILIsym Services Inc., a Simulations Plus company (NASDAQ:SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that it is initiating development of IPFsym™, QSP (quantitative systems pharmacology) modeling software that will provide the ability to predict the efficacy of drugs being developed to treat idiopathic pulmonary fibrosis (IPF). The development of IPFsym is being sponsored by a large pharmaceutical company partner for $2.7 million, and it will be widely available via licensing and consulting for the broader pharmaceutical industry upon completion.

Dr. Scott Q Siler, chief scientific officer of DILIsym Services, said: "IPF is a fatal lung disease that is characterized by a progressive loss of lung function. Genetic and environmental factors compromise the epithelial cells of the lung, leading to pulmonary fibrosis over time. DILIsym Services is leveraging our experience in modeling liver fibrosis in non-alcoholic fatty liver disease with NAFLDsym® to simulate lung fibrosis and other aspects of IPF. There is substantial effort within the pharmaceutical industry to develop effective treatments for IPF, and we believe predictions with QSP modeling software like IPFsym will make the clinical development process more efficient."

IPFsym will include key pathophysiologic mechanisms and clinical aspects of IPF, such as lung fibrosis, alveolar epithelial injury, pulmonary fibrosis, and test of lung function (e.g., forced vital capacity--FVC). IPFsym will also include the ability to simulate disease progression and inter-patient variability in pathophysiologic and clinical characteristics with SimPops®.

Shawn O'Connor, chief executive officer of Simulations Plus, DILIsym's parent company, added: "The sponsored development of IPFsym will provide a valuable predictive modeling and simulation tool that can be used to improve the cost and efficiency of drug development and, importantly, positively support decision making that can directly impact patient safety. This endeavor is another example of our leadership in QSP modeling, including the ability to predict both the efficacy and safety of drugs. Moreover, we are excited that this effort will also include expansion of our flagship PBPK modeling software, GastroPlus, to improve the predictions of compound exposure upon inhalation of drugs."

IPFsym will be available for licensing and consulting services, as is the case with DILIsym Services' other QSP offerings like DILIsym and NAFLDsym.

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; NAFLDsym®, for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options; and a future tool, RENAsym®, for predicting drug-induced kidney injury. More information is available on the company's website at https://www.dilisym.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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