Researchers Use the Simulations Plus DILIsym® Platform to Predict Safety of Combined CBD and VPA Treatment
August 15 2023 - 8:30AM
Business Wire
Elevated ALT levels during clinical trials
led researchers to use quantitative systems toxicology (QST)
software to better understand potential underlying
mechanisms
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of
modeling and simulation software and services for pharmaceutical
safety and efficacy, today shared an article published in the July
2023 issue of Clinical Pharmacology & Therapeutics in which
researchers explained how they used the DILIsym® software platform
to explore why patients receiving treatment with valproate (VPA)
are more sensitive to elevations in liver chemistries due to
cannabidiol (CBD).
DILIsym is a quantitative systems toxicology (QST) software
platform designed to be used during drug development for predicting
drug-induced liver injury (DILI) and can provide insight into the
mechanisms responsible for DILI responses through the development
process.
CBD is an FDA-approved treatment for seizures in patients
diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and
tuberous sclerosis complex. During the pre-approval clinical
trials, treatment with CBD was occasionally associated with
elevation in blood levels of ALT, a marker of liver injury, but
this was much more common in patients already receiving treatment
with VPA for seizures. To identify potential underlying mechanisms,
researchers used DILIsym to predict ALT levels in simulated
populations that were treated with CBD alone, treated with VPA
alone, and then treated with VPA before they were treated with
CBD.
“Since so many people are now taking CBD in over-the-counter
preparations, it was important to understand this effect of VPA to
determine whether there are other drug treatments or patient risk
factors that might increase risk for liver injury due to CBD,” said
Dr. Paul Watkins, senior author on the manuscript and professor at
The University of North Carolina at Chapel Hill.
DILIsym predicted dose-dependent ALT elevations for CBD
treatment and ALT elevations for VPA treatment when each was given
alone, but the combined VPA and CBD treatment protocol mimicking
the clinical trials did not increase the incidence of ALT
elevations relative to CBD treatment on its own.
Watkins continued, “This suggests that VPA-CBD interaction does
not involve the major mechanisms underlying liver injury due to
drugs, which are incorporated into DILIsym. This effect of VPA
might be specific to this drug, reducing concern that there may be
common risk factors.”
“DILIsym provides critical information for researchers in the
pharmaceutical development space faced with decisions regarding the
safety of their drugs and combined therapies,” said Dr. Brett
Howell, President of the DILIsym Services division of Simulations
Plus. “We are committed to supporting our clients in identifying
and mitigating risks in the drug design and development process,
and ultimately to the patients who are awaiting improved
treatments.”
The full article can be found here.
Researchers can learn more about DILIsym or other modeling and
simulation software on the Simulations Plus website.
About Simulations Plus
Serving clients worldwide for more than 25 years, Simulations
Plus is a leading provider in the biosimulation market providing
software and consulting services supporting drug discovery,
development, research, and regulatory submissions. We offer
solutions that bridge artificial intelligence (AI)/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, and regulatory agencies worldwide.
For more information, visit our website at
www.simulations-plus.com. Follow us on LinkedIn | Twitter |
YouTube.
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Simulations Plus Investor Relations
Renee Bouche 661-723-7723 renee.bouche@simulations-plus.com
Financial Profiles Tamara Gonzalez
310-622-8234 slp@finprofiles.com
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