FDA Review of Approved Drug, Ubrogepant, Included DILIsym Simulations
September 02 2020 - 8:30AM
Business Wire
FDA Review Document and New Toxicological
Sciences Publication Detail Results
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP)
and a leading provider of modeling and simulation software for
pharmaceutical safety and efficacy, today announced that
simulations using the DILIsym® software were utilized as part of
the U.S. Food and Drug Administration’s (FDA) review of the safety
of ubrogepant, which has now been approved for use in the U.S.
(UBRELVY™). The utilization of DILIsym results are highlighted in
the “Summary of selected (key) nonclinical findings” section of the
introduction within the FDA’s nonclinical review document as part
of Application Number 211765Orig1s000. The safety assessment of
ubrogepant using DILIsym is also summarized in a new publication in
Toxicological Sciences which includes authors from multiple
organizations.
DILIsym modeling supports key drug development decisions by
predicting potential drug-induced liver injury (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 drug-induced liver
injury will not be an insurmountable obstacle to FDA approval.
Ubrogepant, which was predicted to be safe by DILIsym modeling, is
an excellent and important example of this. DILIsym is the product
of an ongoing public-private partnership (the DILI-sim Initiative)
that involves scientists from the pharmaceutical industry and
academia.
Dr. Paul Watkins, founder of the DILI-sim Initiative and chair
of the DILI-sim Scientific Advisory Board, said: “Before the
pivotal clinical trials of ubrogepant were undertaken, DILIsym
modeling predicted the drug’s liver safety relative to the first
two drugs in class, each of which failed in clinical trials due to
significant liver safety concerns. Ubrogepant is now FDA approved
without even a warning of possible liver toxicity, which I believe
is a first for a next-in-class drug when the first two in any class
had serious liver safety concerns. DILIsym modeling helped support
the decision to proceed with clinical development of ubrogepant,
and I am confident that the modeling results were part of the
weight of evidence that convinced the FDA of ubrogepant’s safety. I
am very proud of the role DILIsym is now playing in speeding
delivery of safe drugs to the patients who need them.”
Dr. Brett Howell, president of DILIsym Services, added,
“Ubrogepant is one of several examples of the prospective use of
DILIsym to help de-risk drug development programs. DILIsym Services
is excited to continue bringing our DILIsym software-related
services, as well as licensing and membership options, to the
pharmaceutical industry so that they can help the patients who need
new and vital medicines.”
Views expressed in this press release do not necessarily reflect
the official policies of the Department of Health and Human
Services; nor does any mention of trade names, commercial
practices, or organizations imply endorsement by the United States
Government.
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.
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.
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 slp@haydenir.com
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