Simulations Plus & the University of Pittsburgh Drug Discovery Institute Receive SBIR Grant Funding for Large Molecule Safety...
February 23 2021 - 8:30AM
Business Wire
Computational Modeling, Human Liver
Microphysiology Systems (MPS) and the MPS-Database Platforms to be
Integrated for Safety Testing
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 and the University of Pittsburgh Drug Discovery
Institute (UPDDI) have jointly received a Phase I NIH-funded SBIR
grant to combine the highly successful DSS software (DILIsym) and
UPDDI’s vLAMPS experimental liver model and the microphysiology
systems database (MPS-Db) to predict the safety of large (macro)
molecules such as proteins that are increasingly used to treat
diseases. The first phase of development funded by the grant will
include beta version software construction and vLAMPS testing of
several large molecules captured in the MPS-Db. Successful
completion of the objectives will lead to an application for a
larger Phase II grant, which would fully fund the development of
the joint commercial offering.
DSS coordinates the DILI-sim Initiative, which is a
public-private partnership that has guided development of the
DILIsym® software package. This software uses properties of drugs
to predict their risk of causing liver injury in patients, and is
now widely used to support key drug development decisions. To date,
this approach has been successfully applied to traditional small
molecule drugs. Similarly, the UPDDI has developed the vLAMPS and
MPS-Db technologies for other drug development applications. The
focus on large molecule safety in an integrated fashion represents
an important new direction for both organizations, allowing them to
support development of safer large molecule therapeutics.
Dr. Paul B. Watkins, the Director of the Institute for Drug
Safety Sciences at University of North Carolina and chair of the
Scientific Advisory Board of the DILI-sim Initiative, said: “Large
molecules, such as monoclonal antibodies, have become the hottest
target for drug development. However, these therapeutics are not
without liver safety liabilities that are currently very hard to
predict. I believe that this collaboration, which received very
high priority for funding, will help solve this problem.”
Dr. Brett A. Howell, President of DILIsym Services, added: “The
development of novel therapeutics involving larger and more complex
molecules is ever-increasing. This collaboration will allow DSS to
remain at the forefront of drug safety prediction innovation and
expand our product offerings.”
Dr. D. Lansing Taylor, Director of the UPDDI, Distinguished
Professor and Allegheny Foundation Professor of Computational and
Systems Biology, stated: “The integration of our biomimetic human
liver MPS (vLAMPS) with the MPS-Db and DILIsym computational
modeling is a powerful application of quantitative systems
pharmacology (QSP) to large molecule safety and will advance large
molecule safety testing.”
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.
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. More information is available on the
company’s web page.
About the University of Pittsburgh Drug Discovery Institute
(UPDDI)
The UPDDI applies QSP and human MPS to understand the mechanisms
of disease progression, as well as to predict potential
therapeutics for diseases such as non-alcoholic fatty liver disease
(NAFLD), type 2 diabetes, cancer and neurodegenerative diseases,
and to identify mechanisms of toxicology.
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,
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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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