DILIsym Releases NAFLDsym® Version 2A

Substantial update of NAFLD drug efficacy software offers a broad range of pathophysiology and over a thousand simulated patients for testing

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 has released NAFLDsym® Version 2A, quantitative systems pharmacology (QSP) modeling software to support the development of treatments for non-alcoholic fatty liver disease (NAFLD).

Dr. Scott Q Siler, chief scientific officer of DILIsym Services, said: “We are excited about the release of NAFLDsym v2A, as we believe it will assist the pharmaceutical industry by bringing effective medications to non-alcoholic steatohepatitis (NASH) patients in a timely and cost-efficient manner. The quantitative systems modeling introduced with NAFLDsym v2A enables users to evaluate key pathophysiologic areas of evaluation in NASH drug development, such as how drug candidates affect steatosis, lipotoxicity, inflammation, and fibrosis. In particular, NAFLDsym v2A allows users to predict efficacy in NASH patients for combinations of treatments, which is thought to be the best path for treating this disease.”

Shawn O’Connor, chief executive officer of parent company Simulations Plus, added: “NAFLDsym v2A is the result of an immense effort by our highly skilled modeling and simulation team and the support of our corporate sponsor. We look forward to the continuing use of predictive modeling and simulation tools to reduce the cost and improve the efficiency of drug development.”

Features include:

  • >1000 simulated patients with variability in pathophysiology, representing the spectrum of NAS and fibrosis; scores allow users to test simulated patient cohorts that align with their intended trial patient characteristics
  • Clinical biomarkers (e.g., MRE, MRI, Pro-C3, NAS, plasma triglycerides, plasma cK18)
  • Fibrosis – test strategies to prevent or reverse the production of extracellular matrix and associated scarring
  • Steatosis – test strategies to prevent or reverse liver lipid accumulation
  • Lipotoxicity – test strategies to prevent hepatocyte loss
  • Inflammation – test strategies to prevent inflammation
  • Weight gain and loss associated disease progression and regression
  • Plus much more…

DILIsym Services recently hosted a webinar introducing the mechanistic underpinnings of NAFLDsym and the exploration of treatments within simulated populations (SimPops®). View the webinar here.

DILIsym Services, Inc., applies NAFLDsym for comprehensive consulting services on drug development decisions. NAFLDsym is also available for direct use. Contact us to receive a free trial version today!

About DILIsym Services, Inc.

DILIsym Services, Inc., was founded in 2015 in Research Triangle Park, North Carolina, and has developed DILIsym and NAFLDsym® QSP software, and is developing IPFsym™ and RENAsym™ QSP software, to provide the pharmaceutical industry with the tools and resources to efficiently develop safe and effective drug therapies. DILIsym and RENAsym are designed to address drug-induced liver injury (DILI) and drug-induced acute kidney injury, respectively. NAFLDsym and IPFsym are designed for target or compound evaluation of therapeutic efficacy in nonalcoholic fatty liver disease (NAFLD or NASH) and idiopathic pulmonary fibrosis (IPF), respectively. Thus, DILIsym and RENAsym may be applied to address drug safety across therapeutic areas, while NAFLDsym and IPFsym may be applied to support the development of efficacious drugs in these therapeutic areas. DILIsym Services makes these tools available to small, mid-size and large pharmaceutical organizations and regulatory agencies through its licensing programs. In addition to performing consulting services using the modeling software, the expert scientific team engages clients from initial program design through data input and “results” interpretation. The company’s mission is to apply its modeling and simulation expertise to support the development of safe and efficacious drug therapies. More information is available on the company’s web page 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 and quantitative systems pharmacology 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 and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods 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.

Contacts

Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

[email protected]

Hayden IR

Mr. Cameron Donahue

651-653-1854

[email protected]

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