Health
AI-designed drug for inflammatory bowel disease enters human clinical trials: 'A significant need'
Inflammatory bowel disease (IBD) impacts 1.6 million people in the U.S. — and a new artificial intelligence-generated drug could help alleviate symptoms.
Insilico Medicine, an AI-driven biotech company based in Hong Kong and in New York City, recently announced that its new AI-designed IBD drug — ISM5411 — has entered Phase I clinical trials.
This is Insilico’s fifth AI-designed drug to enter the pipeline.
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If approved, it would be the first medication to treat IBD by blocking prolyl hydroxylase domain (PHD), a protein that regulates the body’s gut barrier protection genes, according to Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.
“ISM5411 is a potentially first-in-class candidate for the treatment of IBD – this means that it is designed to treat the disease in an entirely new way,” Zhavoronkov told Fox News Digital in an interview.
Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine, is pictured in the company’s New York lab. (Insilico Medicine)
Why the need for a new drug?
IBD, which includes Crohn’s disease and ulcerative colitis, causes debilitating symptoms that include abdominal pain, diarrhea, fatigue, weight loss and rectal bleeding, according to Mayo Clinic.
“This condition is on the rise across the industrialized world, but currently there are no cures and few treatments,” said Zhavoronkov.
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Many current drugs for IBD are anti-inflammatory and rely on immunosuppression to work.
“This carries its own set of risks, as suppressing the immune system can give rise to chronic infection and tumor diseases,” Zhavoronkov said.
Insilico Medicine, an AI-driven biotech company based in Hong Kong and in New York City, recently announced that its new AI-designed IBD drug — ISM5411 — has entered Phase I clinical trials. Fox News Digital spoke with its founder and CEO. (Insilico Medicine)
Other biologic drugs for IBD are administered by IV or self-injection.
“We knew there was a significant need in this space, and we wanted to find a new way to treat IBD that focused on healing and rebuilding the intestinal lining to lead to long-term improvement of the condition rather than just treating the symptoms,” said Zhavoronkov.
Tapping into AI’s power
IBD patients produce significantly more of the PDH protein than those without the condition.
Insilico’s research and development team used Chemistry42, the company’s generative AI chemistry engine, to design a molecule to block the PDH and produce genes that protect the gut barrier.
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“You can think of Chemistry42 as a ChatGPT for new molecules,” said Zhavoronkov.
“But instead of providing text commands and having an AI model generate a new essay or poem based on existing data, our platform draws from biological and chemical data to design an entirely new molecule using our instructions.”
“We knew there was a significant need in this space, and we wanted to find a new way to treat IBD that focused on healing and rebuilding the intestinal lining to lead to long-term improvement of the condition rather than just treating the symptoms,” Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine, told Fox News Digital. (Insilico Medicine)
“Our AI platform designed a number of possible molecules to meet our criteria, and ranked them, and our R&D team synthesized and tested a number of these before selecting ISM5411 as the most promising candidate,” said Zhavoronkov.
An oral medication, ISM5411, is described as “intestinal restrictive,” which means it only works on the gut without impacting other parts of the body, he noted.
“You can think of Chemistry42 as a ChatGPT for new molecules.”
“Very importantly, it promotes mucosal repair,” said Zhavoronkov.
“In other words, we designed this drug to help restore the normal functioning of the gut.”
Previous research has shown that mucosal repair is effective in reducing hospitalization and improving long-term prognosis for IBD patients.
Progress toward approval
Insilico’s IBD drug has officially begun trials in 76 healthy volunteers in Australia to evaluate its safety and tolerability in gradually increasing doses, Zhavoronkov said.
After completing the Phase 1a trial, Insilico plans to launch an international multi-center clinical trial in the U.S., China and other locations, with three treatment groups and one placebo group.
Insilico’s IBD drug has officially begun trials in 76 healthy volunteers in Australia to evaluate its safety and tolerability in gradually increasing doses. (Insilico Medicine )
“Our clinical team is working hard to design and execute the clinical trials in order to develop it further so we can begin helping patients in need,” said Zhavoronkov.
“As we continue to advance this drug, we also look forward to connecting with companies with relevant experience and resources who are interested in co-developing this asset with our team.”
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ISM5411 is one of more than 30 drugs that have been designed by Insilico’s AI platform, including many for cancer — as well as fibrosis, central nervous system diseases and COVID-19.
“As these drugs move from research labs to clinical settings, the public needs to understand the potential and the limitations.”
The company’s lead drug, the first AI-discovered and AI-generated drug to reach Phase II trials with patients, is for the treatment of idiopathic pulmonary fibrosis, a progressive lung condition with an extremely poor prognosis.
Potential benefits and risks
Dr. Supriya Rao, a Massachusetts-based gastroenterologist, was not involved in Insilico’s drug development but offered her input on ISM5411.
“I think it’s very promising,” Rao told Fox News Digital. “Obviously, there will be hurdles to jump through, and data is very novel at this stage of development.”
Inflammatory bowel disease (IBD) impacts 1.6 million people in the U.S., causing symptoms that include diarrhea, abdominal pain, fatigue, weight loss and rectal bleeding. (iStock)
“Longer-term safety and efficacy would be concerns, but we’ve only just begun to embark on a journey of AI and health care,” she added.
All treatments have their pros and cons, Rao noted, particularly with “very individualized diseases” like IBD.
“Could this speed up the recovery process and offer a more targeted treatment plan with minimal side effects? The possibility is exciting,” she said. “Our goal as health care professionals is always to achieve better patient outcomes.”
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AI expert and emergency medicine physician Dr. Harvey Castro from Dallas, Texas, who was also not involved in the development of ISM5411, noted that while promising, these types of AI-generated drugs can carry inherent risks.
“The primary concern is the uncertainty surrounding their long-term effects, as AI-designed drugs are a relatively new medical frontier,” Castro told Fox News Digital.
AI expert and emergency medicine physician Dr. Harvey Castro from Dallas, Texas, weighed in on the potential risks associated with AI-generated drugs. (Dr. Harvey Castro)
“There’s also the challenge of ensuring that the AI algorithms are trained on comprehensive and unbiased data sets, as misinterpretations or gaps in data could lead to ineffective or harmful drugs.”
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Castro noted that existing regulatory frameworks may not adequately address the nuances of AI-driven drug development.
“Public awareness is key,” he said.
“As these drugs move from research labs to clinical settings, the public needs to understand the potential and the limitations,” Castro went on.
“Educating patients and health care providers about how AI-generated drugs are developed and their potential impact on treatment paradigms is vital.”
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Health
Cancer-linked herbicide in the spotlight after controversial order: ‘Toxic by design’
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There has been a shake-up in the Make America Healthy Again movement regarding glyphosate, a widely used herbicide that has been the subject of significant controversy.
The debate follows an executive order signed by President Donald Trump that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense.
MAHA supporters have previously pushed a pesticide-free agenda, warning of potential health harms caused by glyphosate.
Dr. Marc Siegel, Fox News senior medical analyst, said he believes there is sufficient evidence linking glyphosate to neurodegenerative diseases, including ALS, Parkinson’s and multiple sclerosis, to warrant limiting exposure.
President Donald Trump signed an executive order that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense. (AP Photo/Charlie Neibergall)
“With Parkinson’s, this association appears to be due to the gut, vagus nerve and brain axis, where the exposure affects the microbiome in the gut, which then ascends slowly up to the brain, causing the neurodegenerative disease years later,” Siegel told Fox News Digital.
“There is also a growing association being found between high-dose glyphosate or occupational exposure and metabolic disorders, liver disease and some cancers, specifically lymphoma.”
He added, “Growing research backs this. I favor limiting it.”
“When we apply them across millions of acres and allow them into our food system, we put Americans at risk.”
Studies have shown that glyphosate, which is used in products such as Roundup, owned by Monsanto, could raise cancer risk.
In one University of Washington study published in the journal Mutation Research, researchers found that exposure to it increased the risk of non-Hodgkin lymphoma by 41%.
The nonprofit Investigate Midwest, which analyzed data from both the U.S. Geological Survey and the National Cancer Institute, also recently found that pesticides may contribute to cancer rates.
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Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to the report.
Investigate Midwest, which is based in Illinois, interviewed more than 100 farmers, environmentalists, lawmakers and scientists as part of a partnership with the Pulitzer Center’s StoryReach U.S. Fellowship.
Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to one study. (iStock)
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate.
Bill Billings, a resident of Red Oak, Iowa, was diagnosed with cancer in 2014.
“The cancer specialist said, very directly, (my) cancer is a result of being exposed to chemicals,” Billings said in the report.
Kelly Ryerson, founder of Glyphosate Facts and owner of the Instagram account @glyphosategirl, told Fox News Digital her journey researching the herbicide began with her own health struggles.
Ryerson, who is based in California, previously struggled with chronic illness and autoimmune issues, which she said improved when she stopped eating gluten.
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate. (iStock)
After attending a medical conference at Columbia University’s Celiac Disease Center, Ryerson began to question modern farming practices rather than the gluten itself.
“A lot of times, farmers are spraying Roundup on our grains right before harvest to facilitate an easier harvest,” she said. “After that easier harvest, because everything’s dry at the same time, those crops go directly to the mill and may end up in our food supply, at alarmingly high levels.”
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In 2015, the International Agency for Research on Cancer (IARC), part of the World Health Organization framework, classified glyphosate as “probably carcinogenic to humans.”
The classification was based on limited evidence of cancer in humans (notably non-Hodgkin lymphoma in some studies) and sufficient evidence in experimental animals.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” a Monsanto spokesperson said. (Wolf von Dewitz/picture alliance via Getty Images)
A spokesperson for Monsanto told Fox News Digital it will comply with Trump’s order to produce glyphosate and elemental phosphorus.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” the spokesperson said.
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HHS Secretary Robert F. Kennedy Jr. has long been a vocal critic of Roundup, working with his legal team in 2018 to award $289 million to a man who alleged the weed killer caused his non-Hodgkin lymphoma, according to reports.
Following backlash to Trump’s executive order, Kennedy said he supports the order but acknowledged that “pesticides and herbicides are toxic by design, engineered to kill living organisms.”
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“When we apply them across millions of acres and allow them into our food system, we put Americans at risk,” he posted on X. “Chemical manufacturers have paid tens of billions of dollars to settle cancer claims linked to their products, and many agricultural communities report elevated cancer rates and chronic disease.”
Fox News Digital reached out to the White House for comment.
Health
Common nighttime noise exposure may trigger heart problems, study suggests
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Living near heavy traffic could negatively impact your heart health.
A European study, published in the journal Environmental Research, found that exposure to nighttime road traffic noise is linked to changes in the blood, leading to worsened cholesterol and cardiovascular risks.
The researchers considered data from the U.K. Biobank, Rotterdam Study, and Northern Finland Birth Cohort 1966, including more than 272,000 adults over the age of 30, according to a press release.
Nighttime road noise exposure was estimated at all participants’ homes based on national noise maps. Researchers also took blood samples to measure the participants’ metabolic biomarkers for disease, then mapped the link between nightly noise levels and existence of biomarkers.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers. (iStock)
The study found that people exposed to louder noise at night — especially sounds above 55 decibels — showed changes in 48 different substances in their blood. Twenty of these associations “remained robust” throughout all cohorts.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers, especially LDL “bad” cholesterol, IDL (intermediate-density lipoprotein) and unsaturated fatty acids.
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As noise levels increased, starting at around 50 decibels, cholesterol markers rose steadily, the release stated.
The authors concluded that this study “provides evidence that nighttime road traffic noise exposure from 50 dB upward is associated with alterations in blood cholesterol and lipid profiles in adults.”
Researchers noted a link between traffic noise and cardiometabolic disease. (iStock)
Study co-author Yiyan He, doctoral researcher at the University of Oulu in Finland, noted that in this type of research, small effect sizes are expected, and environmental exposures such as traffic noise are “typically modest.”
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“Despite this, we observed statistically robust and consistent associations across many biomarkers, especially those related to LDL and IDL lipoproteins,” she told Fox News Digital.
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“We also identified a clear exposure-response pattern starting at around 50 dB, suggesting that metabolic changes become more evident as noise levels increase.”
This aligns with public health guidance, as the World Health Organization recommends lower nighttime noise limits at around 40 to 45 dB, Yiyan He added.
“This finding may clarify the association between traffic noise and cardiometabolic diseases,” the researchers wrote. (iStock)
“The 55 dB level is often used as an interim benchmark associated with substantial noise annoyance and sleep disturbance,” she said. “In our study, we observed associations not only at 55 dB, but also indications of effects emerging at around 50 dB.”
The strength and consistency of the cholesterol-related associations were surprising, as these changes are usually “subtle.”
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“Instead, we found consistent associations across multiple large European cohorts, which strengthens confidence that the findings may reflect real biological patterns,” Yiyan He went on. “We were also interested to see that effects were minimal below ~50 dB, suggesting a possible threshold-like pattern.”
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The researcher noted that these findings were consistent across genders, education levels and obesity status.
The study was restricted to White Europeans, which posed a limitation. There was also a lack of information on the fasting status in the UK Biobank.
Changes in cholesterol levels were more severe than researchers expected. (iStock)
“Fasting can influence levels of certain metabolites, particularly fatty acids,” Yiyan He said. “However, based on UK Biobank documentation, fewer than 10% of participants were fasting for at least eight hours, and our main findings focused on cholesterol-related biomarkers, which are generally less sensitive to short-term fasting.”
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The researchers also lacked information on bedroom location, indoor noise exposure and time spent at home.
“These factors may introduce non-differential exposure misclassification,” Yiyan He said. “Additionally, noise exposure estimates were based on participants’ temporary residential addresses at the time of blood sampling, without considering the duration of residence.”
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“Many of these limitations would tend to bias results toward the null, so the consistent associations we observed remain noteworthy.”
Experts recommend taking measures to limit traffic noise at night. (iStock)
Based on this latest research, Yiyan He noted that nighttime noise is a “health-relevant exposure,” not just “an annoyance.”
“Our findings suggest that nighttime traffic noise may subtly but consistently affect metabolic health,” she said. “While the changes in cholesterol and lipid levels for any one individual are small, traffic noise affects a very large number of people, which means the potential public health impact could be substantial.”
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The researcher recommends taking measures like improving sound insulation, using noise-reducing strategies and placing bedrooms on the quieter side of the home when possible.
“Because sleep is a key pathway linking noise to health, protecting the nighttime sleep environment is especially important,” she added.
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