Latest news with #DILI
Yahoo
10-06-2025
- Business
- Yahoo
CN Bio introduces cross-species DILI services to enhance in vitro to in vivo extrapolation during preclinical drug development
Extends capabilities of industry-leading PhysioMimix DILI assay for comparative studies between animal species and human Generates deeper insights into inter-species differences to de-risk development pipelines and minimize animal testing CAMBRIDGE, England, June 10, 2025--(BUSINESS WIRE)--CN Bio, a leading provider of Organ-on-a-chip (OOC) systems and solutions that accelerate drug discovery and development workflows, has introduced two new animal microphysiological system (MPS) models that enhance translatability in preclinical drug safety and toxicology assessments to its Contract Research Services (CRS). Building upon the Company's FDA-recognized drug induced liver injury (DILI) assay, the expanded offering enables rapid, comparative studies between commonly used animal and human models to flag interspecies differences early, and better informs in vivo study design. Traditional human in vitro methods have limited capacity to accurately determine drug toxicity. Added to this, the discrepancies between these methods and in vivo animal studies make it challenging to accurately predict safety risks for humans during preclinical testing. Often, unsafe drug candidates are wrongly progressed, and potentially life-saving ones are misclassified and abandoned, ultimately impacting clinical progression. In response to growing market demand for tools that address these concerns, CN Bio has expanded the in vitro to in vivo extrapolation (IVIVE) capabilities of its established PhysioMimix® DILI assay, adding the ability to easily compare results across human-, rat-, and dog-derived Liver-on-a-chip models. These assays offer a modernized workflow to generate predictive and actionable insights that mitigate the risk of costly, late-stage conflicting data, and reduce unnecessary animal use by providing early warning of hepatotoxicity/DILI prior to in vivo studies. Accessible through the Company's CRS, the new offering harnesses the longstanding expertise of CN Bio's scientific team to provide detailed data analysis, optimized outcomes, and data-driven conclusions beyond what is achievable using existing in vitro models. The assay enables a broad range of longitudinal and endpoint testing for DILI-specific biomarkers from single- or repeat-dosing studies over a 14-day experimental window. This provides a more comprehensive overview of underlying mechanisms of hepatotoxicity or latent effects of drug candidates to improve IVIVE assessment and streamline clinical progression. Dr Emily Richardson, Lead Scientist, Safety and Toxicology, CN Bio, said: "Understanding safety risks is critical to successful drug development, however, fundamental physiological and biological differences between species can lead to inaccuracies in predictions, often causing drug candidates to be wrongfully abandoned as toxic, or worse, mistakenly classified as safe." She added: "Having established our DILI assay as an industry leading option to garner more valuable insights across the development pipeline, we were in an ideal position to expand its capabilities and address this crucial gap in understanding hepatotoxicity using the most commonly used animal models. Partnering with us to utilize this powerful service not only ensures robust and reliable results but also provides access to a team of Organ-on-a-chip experts, who are invested in your success; to de-risk your pipeline and move it forward with confidence." View source version on Contacts Media contact Lily JefferyTel: +44(0)7891477378Email: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
10-06-2025
- Health
- Business Wire
CN Bio introduces cross-species DILI services to enhance
CAMBRIDGE, England--(BUSINESS WIRE)--CN Bio, a leading provider of Organ-on-a-chip (OOC) systems and solutions that accelerate drug discovery and development workflows, has introduced two new animal microphysiological system (MPS) models that enhance translatability in preclinical drug safety and toxicology assessments to its Contract Research Services (CRS). Building upon the Company's FDA-recognized drug induced liver injury (DILI) assay, the expanded offering enables rapid, comparative studies between commonly used animal and human models to flag interspecies differences early, and better informs in vivo study design. Traditional human in vitro methods have limited capacity to accurately determine drug toxicity. Added to this, the discrepancies between these methods and in vivo animal studies make it challenging to accurately predict safety risks for humans during preclinical testing. Often, unsafe drug candidates are wrongly progressed, and potentially life-saving ones are misclassified and abandoned, ultimately impacting clinical progression. In response to growing market demand for tools that address these concerns, CN Bio has expanded the in vitro to in vivo extrapolation (IVIVE) capabilities of its established PhysioMimix ® DILI assay, adding the ability to easily compare results across human-, rat-, and dog-derived Liver-on-a-chip models. These assays offer a modernized workflow to generate predictive and actionable insights that mitigate the risk of costly, late-stage conflicting data, and reduce unnecessary animal use by providing early warning of hepatotoxicity/DILI prior to in vivo studies. Accessible through the Company's CRS, the new offering harnesses the longstanding expertise of CN Bio's scientific team to provide detailed data analysis, optimized outcomes, and data-driven conclusions beyond what is achievable using existing in vitro models. The assay enables a broad range of longitudinal and endpoint testing for DILI-specific biomarkers from single- or repeat-dosing studies over a 14-day experimental window. This provides a more comprehensive overview of underlying mechanisms of hepatotoxicity or latent effects of drug candidates to improve IVIVE assessment and streamline clinical progression. Dr Emily Richardson, Lead Scientist, Safety and Toxicology, CN Bio, said: 'Understanding safety risks is critical to successful drug development, however, fundamental physiological and biological differences between species can lead to inaccuracies in predictions, often causing drug candidates to be wrongfully abandoned as toxic, or worse, mistakenly classified as safe.' She added: 'Having established our DILI assay as an industry leading option to garner more valuable insights across the development pipeline, we were in an ideal position to expand its capabilities and address this crucial gap in understanding hepatotoxicity using the most commonly used animal models. Partnering with us to utilize this powerful service not only ensures robust and reliable results but also provides access to a team of Organ-on-a-chip experts, who are invested in your success; to de-risk your pipeline and move it forward with confidence.'
Fox News
02-06-2025
- Business
- Fox News
Common supplements and medications could cause liver damage, studies show
As cases of drug-induced liver injury (DILI) are on the rise, experts are warning of the hidden dangers associated with some common medications and supplements. Statistics show that DILI, also known as toxic hepatitis or hepatotoxicity — which is known to be a significant cause of acute liver failure — has been growing in Western countries since the 1960s. Around one-fifth of the total population who are prescribed medications will experience DILI, according to recent research published in the journal Toxicology Reports. Potential triggers of liver injury include herbal products, dietary supplements and medications, the study found. Those with pre-existing liver conditions and nutritional deficiencies are at a higher risk, as are pregnant women. One of the liver's main functions is to break down substances taken orally, including supplements and medications, according to the American College of Gastroenterology (ACG). For some people, the process of metabolizing these substances can be slower, increasing the risk of liver damage. Even medications that have been tested for safety and approved by the U.S. Food and Drug Administration (FDA) can potentially cause liver injury in rare cases, stated the ACG. Common symptoms of liver disease include nausea, loss of appetite, abdominal pain, generalized itching, dark urine and jaundice, although some people may notice no signs, per the above source. The recent study in Toxicology Reports identified several drugs that are most likely to cause liver injury. Medications aren't the only agents that can cause drug-induced liver injuries. Dr. Marc Siegel, Fox News senior medical analyst, spoke with Fox News Digital about the risks of herbal and dietary supplements (HDS) affecting the liver. "The biggest problem with herbal supplements is that the amount you are taking of active chemicals isn't strictly regulated, so you don't know exactly what you are getting." "The biggest problem with herbal supplements is that the amount you are taking of active chemicals isn't strictly regulated, so you don't know exactly what you are getting," he said. "And since several of the supplements are metabolized through the liver, there is now an increasing incidence of liver toxicity in users." Cases of DILI linked to herbal or dietary supplements have nearly tripled between 2004 and 2014, according to a 2024 study published in JAMA Network Open. The researchers identified the following most commonly used botanical products known for potential liver toxicity. It is estimated that at least 15.6 million U.S. adults have used at least one of these six botanical products within the past 30 days. "The most commonly implicated botanical products in the DILIN (Drug-Induced Liver Injury Network) include turmeric, kratom, green tea extract and Garcinia cambogia, with potentially severe and even fatal liver injury," the study stated. Drug-induced liver injury caused by HDS can be severe or even fatal, leading to death or liver transplantation, the researchers noted. Fox News' Siegel also warned against the potential liver-related risks of some of these named supplements. "Turmeric is a natural anti-inflammatory and may be useful in small doses, but can be toxic in large doses," he cautioned. "Garcinia cambogia is very popular, especially as a weight-loss agent, but there is no real evidence that it actually works, and there is no reason to take it, especially with the new GLP-1 drugs." While red yeast rice has cholesterol-lowering statin-type properties, Siegel cautioned that the amount of active chemicals isn't as strictly regulated as approved medications. "Turmeric is a natural anti-inflammatory and may be useful in small doses, but can be toxic in large doses." "I find it useful in some patients who are reluctant to start statins and are looking for a more natural alternative, but I must strictly monitor the amount taken and the effect on the liver," he said. Regarding green tea, Siegel noted that it does have antioxidant properties and can be useful to consume as a beverage (though it has a lot of caffeine) — "but there is no reason whatsoever to take more of it in an extract, where it can be toxic." The FDA states on its website that it does regulate dietary supplement products and dietary ingredients, but under "a different set of regulations than those covering 'conventional' foods and drug products." "Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded," the agency says. "That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations." For more Health articles, visit Fox News Digital reached out to several researchers and the FDA regarding the rise in drug- and HSD-related liver injury.
Daily Mail
29-05-2025
- General
- Daily Mail
Supplements taken by millions linked to deadly liver disease as victims share warning to others
A New Jersey father-of-five is warning people not to take herbal supplements after he was left fighting for his life due to a liver injury that he believes was caused by the remedy. Robert Grafton, 54, had been taking multiple natural supplements in an effort to improve his health, including one with turmeric in it. In early March, the former radiology technologist added something new to his regimen - a turmeric-based liquid supplement. He had seen it advertised for improving liver health on social media. However, a week later, Grafton noticed his urine had turned dark, he felt nauseous, lost his appetite and was constantly itchy. Believing his deteriorating health was tied to the supplements, he stopped consuming them and went to the hospital out of fear that he was suffering from liver failure. Testing revealed he had a drug-induced liver injury, or DILI, which caused damage to his liver due because of his excessive turmeric consumption. A DILI is often caused by any kind of medication or supplement that claims to promote muscle growth or reduce stress. These types of supplements often contain similar ingredients that can harm the liver when consumed in excess. Grafton told NBC: 'My liver enzymes were super elevated, my bilirubin (a yellowish pigment produced after red blood cell breakdown) was really high - all the signs of liver failure. 'I pretty much broke down, my wife as well. I was, at that point, thinking it was liver cancer, pancreatic cancer or something. 'It turns out I had something called a drug-induced liver injury, which came from my supplements.' The liver is responsible for numerous bodily functions, including filtering blood, processing nutrients and detoxifying the body of harmful substances, such as alcohol and drugs. It is also responsible for providing support to the immune system, clotting blood and producing bile, a fluid that helps digest fats and absorb nutrients. However, sometimes an excessive consumption of ultra-concentrated supplements, whether they are of natural ingredients or those chemically made, can cause an injury if the liver isn't able to effectively filter them out of the body, causing them to build up in toxic amounts. Dr Dina Halegoua-De Marzio, a hepatologist who treated Grafton told NBC: 'I think people assume these things are safe. 'The Number one reason we see people taking these are for good health or to supplement their health and so I don't think that they realize that there is a real risk here.' She noted that even though Grafton had stopped taking supplements after noticing he was sick, a turmeric overload had already occurred in his body and caused an injury. Grafton was taking turmeric pills that contained 2,250 milligrams of curcumin, a substance that comes from the root of the turmeric plant and black pepper extract. While it remains unclear which turmeric-filled supplement Grafton took, an average turmeric and curcumin supplement tablet brought at common convenience stores contains 500mgs of the spice. Experts claim a daily consumption of less than 2,000mgs of turmeric through supplements is considered safe. Dr Halegoua-De Marzio said: 'When you cook with turmeric, that could be really safe. But some of the supplements now are 2,000mgs plus, which is a very high dose of turmeric. 'Coupled with black pepper, the liver now has to break down that supplement and it can't. It could make it really sick.' Numerous studies have shown turmeric can improve liver health by decreasing inflammation, reducing the accumulation of fat and detoxifying the organ. However, other studies suggest natural supplements made with turmeric can also cause serious liver injury. A 2010 peer-reviewed study showed over 40,000 Americans report liver damage due to medications and supplements annually - out of which over 2,000 end up dying because of the severity of their condition. But despite scientific evidence, herbal supplements continue to become more popular. A 2024 JAMA Network study found that turmeric is the most commonly consumed supplement in the US, followed by green tea extract, ashwagandha, Garcinia cambogia, red yeast rice and black cohosh. The researchers found 15.6million Americans take supplements containing at least one of these six botanicals - mostly without a doctor's advice. The Food and Drug Administration considers herbal supplements as dietary supplements and does not regulate, oversee or approve them. Therefore, it is impossible for consumers to know whether they re actually consuming what is advertised or if it is safe. Grafton is not the only person to suffer from DILI or serious liver damage due to a supplement. In April 2025, Jenny Ramirez, experienced liver failure due to a typically innocuous ingredient called methylsulfonylmethane (MSM), which is in common over-the-counter vitamins that claim to improve hair, skin and nail health. Research has found MSM to be generally benign and even protective against liver damage. Some scientists have said, however, that MSM could exacerbate liver damage in people with pre-existing liver disease, though research and data are limited. Still, Ramirez became jaundiced, with yellowing skin and eyes. She also had to undergo surgery to remove her gallbladder because of hard deposits that had built up there, blocking the flow of bile through the liver and gallbladder. And in 2023, a 45-year-old woman was found to be suffering from herbal supplement-induced liver injury after she complained of gastric pain and nausea from consuming an herbal tea for three days to improve immunity. Responding doctors noted she showed no signs of jaundice, had a non-tender abdomen and showed signs of liver infection such as Hepatitis A. But after a series of tests and exams, they found that the presence of reishi mushroom, aloe vera and Siberian ginseng - all natural herbs - had caused her pain. As for Grafton, after finding out he had a liver injury, Grafton said his blood work had returned to normal within weeks of ceasing the supplements. Additional testing revealed no permanent damage to his liver. He said: 'The whole push with that is that you're getting a super-high, concentrated dose of turmeric and dandelion root and milk thistle, which I have always known from my medical past is good for liver health. 'It all sounded good, I thought I did enough digging.'
Yahoo
15-05-2025
- Health
- Yahoo
Simulations Plus Releases DILIsym® 11
Newest version of the quantitative systems toxicology (QST) software supports drug-induced liver injury (DILI) prediction for pediatric patient populations RESEARCH TRIANGLE PARK, N.C., May 15, 2025--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus"), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced the release of DILIsym® 11, the latest version of its flagship quantitative systems toxicology (QST) platform. "Advancing toxicology research and improving the prediction of drug-induced liver injury (DILI) are essential to developing safer treatments," said Shawn O'Connor, Chief Executive Officer of Simulations Plus. "DILIsym continues to set the standard by enabling researchers to assess potential liver safety risks, as well as explore dosing strategies that optimize patient safety. We are proud to support innovation that directly impacts patient health and drug development success." "The addition of pediatric representation is an important milestone in predictive toxicology," said Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions of Simulations Plus. "By advancing the evaluation of potential liver safety risks in children, DILIsym 11 will support the development of safer and more effective therapies for children across the globe. We are proud of our role in developing leading-edge modeling tools that help bring better treatment options to vulnerable patient populations." DILIsym is a software platform designed to predict potential DILI hazards and provide insight into the mechanisms responsible for observed DILI responses. It is the most widely used QST modeling software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the U.S. Food and Drug Administration's (FDA) DILI team. DILIsym 11 offers new pediatric representation for exploratory predictions regarding liver safety to children, and a new T-cell model that allows for better understanding of putative contributions of CD8+ T-cell mediated hepatocellular injury. It also includes improved representation of bile acid and cholestatic liver injury, updated antioxidant adaptation mechanisms, and more. Learn more about DILIsym 11 and request your evaluation license. About Simulations Plus, Inc. With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at Follow us on LinkedIn | X | YouTube. Environmental, Social, and Governance (ESG) 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 2024 ESG update. Forward-Looking Statements Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like "believe," "will," "can," "believe," "expect," "anticipate" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) mean that these are our best estimates as of this writing, but 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. Forward-looking statements contained in this press release include, but are not limited to, statements about expectations for the second half of 2025 and anticipated projections for fiscal year 2025. Factors that could cause or contribute to such differences include, but are not limited to: our ability to integrate our ALI and MC business units, our ability to meet our stated guidance, 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, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual and current reports and filed with the U.S. Securities and Exchange Commission. View source version on Contacts Financial Profiles Lisa Fortuna310-622-8251slp@
