DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 6A
August 08 2017 - 8:30AM
Business Wire
Significant update of liver safety program
includes performance and capability enhancements
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 Version 6A 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 v6A 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 this
process of developing DILIsym for optimal use through the DILI-sim
Initiative as we enter Stage 3 of the consortium over the next
three years.”
Dr. Brett Howell, President of DILIsym Services, added, “This
new release of DILIsym is the result of many months of intense
effort by our talented modeling and simulation team and the support
of our member companies. It reflects the priorities of the
pharmaceutical liver safety community, as represented by the member
companies of the DILI-sim Initiative, and we are excited to make
this new product available to the members.”
A sample of the enhancements include:
- New validation compounds (ambrisentan,
sitaxsentan, phenformin, nelfinavir)
- New simulated population focused on
biomarker variability, SimPops™ (v6A-1), with variability in
alanine aminotransferase (ALT) parameters
- New capability for population-level PK
data input (for enhanced compatibility with Simulations Plus’
GastroPlus™ and other PBPK programs)
- Substantial improvements in the PBPK
submodel
- Addition of TNF-α-mediated survival and
regeneration for better representation of pleiotropic
functionality
- Updated DILIsym documentation
resources, now embedded within the software
Walt Woltosz, chairman and chief executive officer of parent
company Simulations Plus, said, “This major release follows our
first two months of operations with DILIsym Services, and we are
very pleased with the operation and organization of our new
division. I like to say that we sell productivity for drug
development, and simulation and modeling software provides a
tremendous bang for the buck. The DILIsym software provides
important information to pharmaceutical companies regarding the
potential for drug-induced liver injury from new and existing
compounds, and this information synergizes well with GastroPlus and
other modeling solutions from Simulations Plus. Project managers
can make more informed decisions with respect to taking new
compounds forward or switching to alternate compounds based on the
insight gained through DILIsym into the likelihood of liver
toxicity prior to conducting expensive and time-consuming clinical
trials.”
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. 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
as filed with the U.S. Securities and Exchange Commission.
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Simulations Plus Investor
RelationsMs. Renee Bouche,
661-723-7723renee@simulations-plus.comorHayden IRMr. Cameron Donahue,
651-653-1854cameron@haydenir.com
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