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AI-designed drug for inflammatory bowel disease enters human clinical trials: 'A significant need'

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AI-designed drug for inflammatory bowel disease enters human clinical trials: 'A significant need'

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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.

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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)

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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.

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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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FIRST AI-GENERATED DRUG ENTERS HUMAN CLINICAL TRIALS, TARGETING CHRONIC LUNG DISEASE PATIENTS

“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.

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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. 

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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.

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“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.

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“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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Loneliness may be silently eroding your memory, new research reveals

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Loneliness may be silently eroding your memory, new research reveals

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Feeling lonely may take a toll on older adults’ memory — but it may not speed up cognitive decline, according to a new study.

Researchers from Colombia, Spain and Sweden analyzed data from more than 10,000 adults ages 65 to 94 across 12 European countries and found those who reported higher levels of loneliness did worse on memory tests at the start of the study, according to research published this month in the journal Aging & Mental Health.

Over a seven-year period, however, memory decline occurred at a similar rate regardless of how lonely participants felt.

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“The finding that loneliness significantly impacted memory, but not the speed of decline in memory over time was a surprising outcome,” lead author Dr. Luis Carlos Venegas-Sanabria of the School of Medicine and Health Sciences at the Universidad del Rosario said in a statement.

Loneliness may be linked to memory performance in older adults, a new study suggests. (iStock)

“It suggests that loneliness may play a more prominent role in the initial state of memory than in its progressive decline,” Venegas-Sanabria said, adding that the findings highlight the importance of addressing loneliness as a factor in cognitive performance.

The findings add to debate about whether loneliness contributes to dementia risk. While loneliness and social isolation are often considered risk factors for cognitive decline, research results have been mixed.

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The study looked at data from the long-running Survey of Health, Ageing and Retirement in Europe (SHARE), which tracked 10,217 older adults between 2012 and 2019. Participants were asked to recall words immediately and after a delay to measure memory performance.

Social isolation and loneliness could play a surprising role in cognitive health among seniors. (iStock)

Loneliness was assessed using three questions about how often participants felt isolated, left out or lacking companionship.

About 8% of participants reported high levels of loneliness at the outset. That group tended to be older, more likely to be female and more likely to have conditions such as depression.

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Researchers found that those with higher loneliness had lower scores on both immediate and delayed memory tests at baseline. Still, all groups — regardless of loneliness level — experienced similar declines in memory over time.

The results suggest loneliness may not directly accelerate the progression of memory loss, though it remains linked to poorer cognitive performance overall.

Researchers look at a brain scan at the National Institutes of Health in Bethesda, Maryland. (Saul Loeb/AFP/Getty Images)

Experts warn, however, that the findings should not be interpreted to mean loneliness is harmless.

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“The finding that lonely older adults start with worse memory but don’t decline faster is actually the most interesting part of the paper, and I think it’s easy to misread,” said Jordan Weiss, Ph.D., a scientific advisor and aging expert at Assisted Living Magazine and a professor at NYU Grossman School of Medicine.

“It likely means loneliness does its damage earlier in life, well before people show up in a study like this at 65-plus,” Weiss told Fox News Digital.

By older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold, an aging expert says. (iStock)

He suggested that by older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold.

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“By the time you’re measuring someone in their late 60s, decades of social connection patterns are already baked in,” he said.

Weiss, who was not involved in the research, added that loneliness may coincide with other health conditions, and noted that participants who felt more isolated also had higher rates of depression, high-blood pressure and diabetes. The link, he said, may reflect a cluster of health risks rather than a direct cause.

“While they can go hand-in-hand, it’s not clear that loneliness contributes to dementia,” a psychotherapist says. (iStock)

Amy Morin, a Florida-based psychotherapist and author, said the findings reflect a broader pattern in research on loneliness and brain health, and that the relationship may be more complex than it appears.

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“The evidence shows there’s a link between loneliness and cognitive decline but there’s no direct evidence of a cause and effect relationship,” she said. “So while they can go hand-in-hand, it’s not clear that loneliness contributes to dementia.”

Morin added that loneliness, which can fluctuate, may not be the root of the problem, but rather a symptom of other underlying mental or physical health issues.

Researchers suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging. (iStock)

She said staying socially and mentally engaged is crucial for overall brain health.

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“It’s important to be proactive about social activities,” Morin said. “Joining a book club, having coffee with a friend, or attending faith-based services can be a powerful way to maintain connections in older age.”

The researchers also suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging.

Fox News Digital reached out to the researchers for comment.

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Eat More To Lose Weight? She Dropped 55 Pounds by Having 5 Meals a Day

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Eat More To Lose Weight? She Dropped 55 Pounds by Having 5 Meals a Day


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Intermittent fasting’s real benefit may come after you start eating again

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Intermittent fasting’s real benefit may come after you start eating again

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Research continues to uncover new details on how fasting may help extend life.

A new study published in the journal Nature Communications investigated how intermittent fasting can boost longevity in small worms often used in aging research.

Researchers from the University of Texas Southwestern Medical Center in Dallas compared worms that were fed normally to those that underwent a 24-hour fast in early adulthood and were then fed again, according to a press release.

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The scientists measured a variety of factors, including stored fat, gene activity related to fat metabolism and lifespan.

The results showed that the life-boosting benefit did not depend on the fasting itself but on the body’s behavior after eating again.

Experts say sustainability is key when choosing a long-term weight-loss strategy. (iStock)

Study lead Peter Douglas, associate professor of molecular biology and a member of the Hamon Center for Regenerative Science and Medicine at UT Southwestern, suggested that these discoveries “shift the focus toward a neglected side of the metabolic coin – the re-feeding phase.”

“Our data suggest that the health-promoting effects of intermittent fasting are not merely a product of the fast itself, but are dependent on how the metabolic machinery recalibrates during the subsequent transition back to a fed state,” he said.

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“Our findings bridge a gap between lipid metabolism and aging research,” he added. “By targeting aging, the single greatest risk factor for human disease, we move beyond treating isolated conditions toward a preventive model of medicine that enhances quality of life for all individuals.”

Lauri Wright, director of nutrition programs at the University of South Florida’s College of Public Health, called this a “high-quality” study that adds an “important nuance to how we think about fasting and longevity.”

Intermittent fasting typically involves limiting meals to an eight-hour daily window or fasting every other day. (iStock)

The benefits of the refeeding phase after fasting were “especially interesting,” Wright, who was not involved in the study, told Fox News Digital.

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“The researchers showed that longevity was linked to the body’s ability to turn off fat breakdown after fasting, allowing cells to restore energy balance,” she reiterated.

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“From a scientific standpoint, that’s a meaningful shift because it suggests fasting is not just about burning fat, but about metabolic flexibility.”

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Fasting may support longevity through triggering metabolic switching, enhancing cellular repair and stress resistance and improving markers like insulin sensitivity, research shows.

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Limitations and cautions

Although this study provides “important insight” on the power of refeeding, Wright noted that the findings should be approached with caution, as the study was done on worms and cannot always be translated to humans.

“Additionally, it explains how a process might work in a controlled lab condition rather than real-world eating behaviors,” she added as a limitation. “Finally, the study is short-term and doesn’t give us the long-term translation on lifespan outcomes.”

The review found intermittent fasting was barely more effective than doing nothing, according to the study authors. (iStock)

Wright cautioned that fasting is “not a magic solution for longevity, and how you eat overall matters more than when you eat.”

“I advise, first and foremost, to focus on diet quality, including a variety of fruits and vegetables, healthy fats and minimally processed foods,” she said.

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For those who are considering fasting, it’s better to stick with a moderate plan — like a 12- to 14-hour overnight fast — rather than going to extremes, Wright said. After fasting, she recommends focusing on well-balanced meals.

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Several groups of people should be cautioned against fasting, according to Wright, including those with diabetes who are on insulin or hypoglycemic medications, those who are pregnant or breastfeeding, anyone with a history of eating disorders and older adults at risk of malnutrition.

Anyone considering intermittent fasting should consult with a doctor before starting.

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