Researchers Use the Simulations Plus DILIsym® Platform to Predict Safety of Combined CBD and VPA Treatment

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CBD is an FDA-approved treatment for seizures in patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.

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화요일, 8월 15, 2023
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Technology, Health Technology, Software, Biotechnology, Other Health, Health, Pharmaceutical, Data Management, Artificial Intelligence, Seizure, Drug development, SLP, Clinical Pharmacology & Therapeutics, Lennox–Gastaut syndrome, Simulations Plus, QST, Chapel Hill, Liver injury, Dravet syndrome, Risk, Hepatotoxicity, Drug design, Incidence, Patient, Manuscript, University, History of the University of North Carolina at Chapel Hill, ALT, FDA, Therapy, VPA, Cannabidiol, Safety, Medical device, Dietary supplement, Pharmaceutical industry, CBD
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UNITED STATES, NORTH AMERICA, CALIFORNIA, NORTH CAROLINA
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Organisation: 
SIMULATIONS PLUS, SIMULATIONS PLUS, INC.
Stock Symbol: 
NASDAQ:SLP
요약
Key Points: 
  • 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.
  • 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.


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).

DILIsymis 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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We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2022 ESG update.

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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