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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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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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Cheap surgery overseas may come with devastating complications, doctors warn

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Cheap surgery overseas may come with devastating complications, doctors warn

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More than three million people travel to undergo cosmetic surgery each year, statistics show — but the potential savings come at a cost.

Most people opting to pursue this so-called “medical tourism” are chasing budget-friendly price tags. 

International surgeries, such as hair transplants in Turkey, can cost as little as $4,000 to $5,000 compared to $20,000 to $30,000 in the U.S., but often come with extreme risks, according to board-certified plastic surgeon Dr. Sheila Nazarian of California.

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The doctor recently joined Lisa Brady on the “The FOX News Rundown” podcast to discuss the rising trend of medical tourism. One of the biggest risks, she said, is the lack of safety regulations in popular destinations like Mexico and Turkey.

As demand spikes in these medical tourism “mills,” there have been reports of non-medically trained staff performing procedures like hair transplants.

Most people opting to pursue “medical tourism” are chasing budget-friendly price tags.  (iStock)

“I’ve heard that they [international clinics] are even recruiting people who maybe were taxi drivers and then putting them through their own training program … to become hair transplant technicians,” Nazarian said. “That’s how high the demand has become.”

In the U.S., medical school graduates are granted a “physician and surgeon” license, which means doctors — including pediatricians or OB-GYNs — can legally perform cosmetic surgeries, even if they didn’t receive specialized training for those procedures during residency, Nazarian noted.

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Instead of pinching pennies, the doctor recommended paying whatever amount is necessary to ensure quality treatment.

“People think of it as, you know, going to the mall. … It’s surgery, and surgery has risks,” she said. “You need to be with someone who not only can perform a beautiful surgery, but who can handle possible complications well.”

“You need to ask them: ‘What was your residency training in? And if you wanted to, would you be allowed to do this procedure in a hospital?’”

Aftercare is another critical factor in the success and safety of a cosmetic procedure, as the doctor emphasized that 20% of a surgical result depends on post-operative care.

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This can be difficult or even impossible to manage when a doctor is in a different time zone, she cautioned, or if the clinic disappears shortly after the procedure.

Nazarian also noted the importance of addressing the psychological component of plastic surgery, noting that no procedure will fix underlying unhappiness. The doctor said she uses screening questionnaires to ensure that patients are truly seeking self-improvement rather than a “cure” for deeper issues.

International surgeries, such as hair transplants in Turkey, can cost as little as $4,000 to $5,000 compared to $20,000 to $30,000 in the U.S., but often come with extreme risks. (iStock)

“If you’re not already generally very content with your life, a knife in my hand is not going to bring you there,” Nazarian said.

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“The analogy I always give is you don’t want a paisley couch — you want a neutral couch and you can put paisley pillows on it,” she said, noting that a procedure should “make you look normal, God-given, athletic. And then you can change your clothes when the trends come and go.”

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Samuel Golpanian, M.D., a double board-certified plastic surgeon in Beverly Hills, said he has also seen an increasing number of patients undergoing cosmetic procedures abroad, sometimes with “devastating consequences.”

“The key is being extremely careful before embarking on this journey.”

“I’ve seen a wide range of complications, including infections, poor wound healing, significant scarring and tissue necrosis (skin death),” he told Fox News Digital. “These complications often lead to prolonged pain, ongoing medical problems, and significant additional costs to repair the damage.”

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Golpanian said he’s treated patients who received unsafe or non-medical-grade injectable materials, which can lead to serious long-term health issues.

One surgeon said he’s treated patients who received unsafe or non-medical-grade injectable materials, which can lead to serious long-term health issues. (iStock)

“I’ve also seen damage to underlying structures, asymmetry and results that are extremely difficult — sometimes impossible — to correct.”

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“That said, I’ve also seen some good outcomes, so it’s not all bad,” he noted. “The key is being extremely careful before embarking on this journey.”

Quick tips for safe ‘medical tourism’

Fully vet the surgeon. “Most surgeons will provide information about their education and training, but it’s important not to accept these claims at face value,” Golpanian said. “Verify them directly by contacting the institutions where they trained.”

Ask for references from prior patients. Ideally, it’s best to get references from U.S.-based patients who can speak candidly about both their experience and their results, the surgeonsaid.

Think beyond the cost. Golpanian emphasized the adage “you get what you pay for.” “Cost should take a back seat to experience, training, judgment and proven results,” he advised.

Be cautious about relying on before-and-after photos. These can be selective or even enhanced, Golpanian warned.

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Keep aftercare in focus. “Make sure the practice emphasizes comprehensive follow-up care and has a clear, realistic post-operative plan in place.”

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