DILIsym Releases NAFLDsym® Version 2A
June 27 2019 - 8:30AM
Business Wire
Substantial update of NAFLD drug efficacy
software offers a broad range of pathophysiology and over a
thousand simulated patients for testing
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.
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Simulations Plus Investor Relations
Ms. Renee Bouche 661-723-7723 renee@simulations-plus.com
Hayden IR Mr. Cameron Donahue
651-653-1854 cameron@haydenir.com
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