U.S. FDA Renews Licenses of DILIsym Software
April 20 2021 - 8:30AM
Business Wire
FDA Renewal Allows for Evaluation of DILIsym
Submissions by Sponsors
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of
modeling and simulation software and services for pharmaceutical
safety and efficacy, today announced that its DILIsym Services
(DSS) division has renewed licenses to its DILIsym® software
platform, its flagship quantitative systems toxicology (QST)
software for predicting and investigating drug-induced liver injury
(DILI), for use by the U.S. Food and Drug Administration (FDA). The
renewal ensures continued DILIsym software access to FDA employees
across all FDA divisions at the FDA’s discretion through an
unlimited licensing package.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of
the DILI-sim Initiative, remarked, “It is not surprising that the
FDA continues to see value in maintaining access to the DILIsym
software in-house, as they are now frequently seeing results from
the software in regulatory submissions, including NDA applications.
It’s clear that results for DILIsym modeling can be an important
part of the weight of evidence supporting the liver safety of new
drug candidates.”
Dr. Brett Howell, president of the DILIsym Services division,
added: “DILIsym is helping drug developers better predict and
understand liver injury. There are now several public examples of
this, including work focused on ubrogepant, lixivaptan, tolvaptan,
remdesivir, pexidartinib, solithromycin, entolimod, acetaminophen,
and GGF2. Many other examples are ongoing or completed but not yet
public. It is, therefore, great to see the FDA maintaining DILIsym
access to potentially evaluate the DILIsym submissions received and
to potentially do further analyses.”
Simulations Plus will host a panel discussion on April 29, 2021,
featuring key leaders in the drug development and liver safety
spaces. Dr. Lorenzo Pellegrini, COO of Palladio Biosciences, Dr.
Vlad Coric, CEO of Biohaven Pharmaceuticals, and Dr. Paul B.
Watkins, a world-renowned DILI expert consultant and Distinguished
Professor at the University of North Carolina, will join the panel
to take questions regarding the use of QST tools (such as DILIsym)
within drug development. Register for the FREE webinar here.
DILIsym modeling supports key drug development decisions by
predicting potential DILI risk of new drug candidates. The modeling
also identifies the biochemical events that lead to DILI caused by
a drug and can thereby predict certain subgroups of patients at
increased risk for DILI from that drug. The information from
DILIsym modeling serves to help guide go/no-go decisions on major
drug development projects, potentially avoiding the disastrous
financial effects of failed clinical trials, or better, providing
assurances that DILI will not be an insurmountable obstacle to
regulatory approval. For the past 10 years, the DILIsym Services
division has coordinated the DILI-sim Initiative, which is a
public-private partnership that has guided development of the
DILIsym software package. DILIsym is available to the
pharmaceutical and chemical industries for direct use to predict
and understand liabilities via membership in the DILI-sim
Initiative consortium and/or commercial licenses. The DILIsym
Services division also routinely uses DILIsym for comprehensive
consulting services on safety-related issues.
Contact us to receive a free trial version today!
About Simulations Plus, Inc.
Simulations Plus, Inc., is a leading provider of modeling and
simulation software and consulting services supporting drug
discovery, development research, and regulatory submissions. With
our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer
solutions which bridge machine learning, physiologically based
pharmacokinetics, quantitative systems pharmacology/toxicology, and
population PK/PD modeling approaches. Our technology is licensed
and applied by major pharmaceutical, biotechnology, chemical,
consumer goods companies and regulatory agencies worldwide. For
more information, visit our website at www.simulations-plus.com.
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Governance (ESG) Report.
The DILIsym Services division of Simulations Plus 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.
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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 slp@haydenir.com
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