DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym Version 7A

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- DILIsym Service, 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 has released Version 7A of its flagship QSP (quantitative systems pharmacology) modeling program, DILIsym®.

Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “We are excited to release DILIsym v7A to the members of the DILI-sim Initiative so they can continue using the software to improve the efficiency of the drug development process. The important updates and new features included are the direct result of feedback from our member companies and the oversight of the Scientific Advisory Board. We look forward to continuing to partner with DILI-sim Initiative member companies to further improve its predictive power.”

Dr. Brett Howell, President of DILIsym Services, added, “This latest release of DILIsym is the result of intense effort by our talented modeling and simulation team and the support of our member companies. It includes exciting new tools for improving the usability of the software, and we are thrilled to make version 7A available to the members.”

A sample of the enhancements includes:

• New validation compounds (tolvaptan, lixvaptan, erythromycin, clarithromycin, azithromycin, solithromycin, telithromycin and BMS-932481)
• New Optimization interface added allowing complex fitting using genetic algorithms
• New Clinical Monitoring feature allowing dynamic clinical trials with dose alterations based on specified thresholds
• New Weight Adjusted Dosing option
• New Export enhancements providing better information on simulation setup within exported Excel file
• MATLAB 2017b friendly – faster simulations (delivered in MATLAB 2017b Runtime environment)
• 2 NEW SimPops
  • Combined ALT biomarker parameter variability with toxicity pathway parameters
  • Mitochondrial biogenesis parameter variability added to SimPops with toxicity pathway parameters
• NEW feature allowing for creation of Custom SimCohorts from existing SimPops / SimCohorts
• UPDATED Initial Conditions infrastructure allowing for importing of custom SimPops in compiled version
• UPDATED Output Table with more clinically important metrics built in
• DILIsym documentation resources updated for new features

Walt Woltosz, chairman and chief executive officer of parent company Simulations Plus, said: “The DILIsym team has pushed the state-of-the-art forward for the simulation of drug-induced liver injury in the DILIsym platform. Version 7A’s advances provide important new capabilities to enable our customers to better assess the potential for liver damage from new and existing drug compounds. Drug-induced liver injury can result in extreme financial loss when a drug development project has to be canceled, so identifying the potential for it, as well as how serious it might be, needs to be done as early in development as possible. Avoiding a disaster in expensive clinical trials or even post-approval can inform a manager’s decision to switch to an alternate molecule or to identify situations that can be managed to minimize liver injury to an acceptable level.”

About DILIsym Service, 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. More information is available on the company’s Web site 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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