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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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Punch the monkey, viral star, experiences dramatic breakthrough among zoo mates

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Punch the monkey, viral star, experiences dramatic breakthrough among zoo mates

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In a dramatic turn of events that’s captured the attention of animal lovers worldwide, Punch — the young macaque at a zoo in Japan famous for his inseparable bond with a stuffed orangutan toy — has reached a major milestone in his journey toward social integration.

On Thursday, visitors and staff at the Ichikawa Zoological and Botanical Garden witnessed a breakthrough: Punch was seen cuddling with and hitching a ride on the back of a fellow macaque.

Punch’s story began with hardship. He was abandoned by his mother shortly after his birth in July 2025 — and to ensure his survival, zookeepers stepped in to hand-rear the primate.

On Jan. 19, 2026, the zoo officially began the process of reintegrating Punch into the “monkey mountain” enclosure.

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The transition was initially fraught with tension. 

Punch’s story began with hardship when he was abandoned by his mother shortly after he was born. To help him, zookeepers gave him a stuffed toy that he began dragging around everywhere he went.  (David Mareuil/Anadolu via Getty Images)

As a hand-reared infant, Punch was bullied and ignored by the established group of monkeys.

He was often seen huddled alone with his orange plush companion while the rest of the troop interacted.

BABY MONKEY CARRIES FAITHFUL STUFFED COMPANION EVERYWHERE HE GOES, DRAWING CROWDS AT ZOO

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In an official statement released Feb. 27, the Ichikawa Zoological and Botanical Garden detailed the meticulous care behind this process.

Previous viral videos showed Punch bullied by the rest of the troop, running to his plushy toy for comfort. (David Mareuil/Anadolu via Getty Images)

“From an animal welfare perspective, our primary goal is to reintegrate Punch with the troop,” the zoo said. 

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The strategy involved nursing Punch within the enclosure, so the troop could recognize him as one of their own, and pairing him with a gentle young female macaque prior to his full release to build his confidence.

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The latest footage, captured by X user @tate_gf, suggested the zoo’s patience is paying off. 

The video shows Punch seeking physical contact not from his toy, but from another monkey — eventually climbing onto its back for a vital social behavior for young macaques: the “piggyback ride.”

The zoo’s strategy appears to be paying off: Punch, shown at far left, was recently seen riding on the back of a fellow macaque. (David Mareuil/Anadolu via Getty Images)

While Punch still carries his stuffed toy for comfort during moments of perceived danger, the zoo remains optimistic about his progress. 

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The organization cited the successful 2009 case of Otome, another hand-reared macaque who eventually outgrew her stuffed toy, successfully integrated — and went on to raise four offspring of her own.

The zoo has had crowds coming to see Punch, with hundreds of people lining up to get inside to see the young star, according to reports. 

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“I’m hoping Punch has a good life like everybody else does, and think he’s a cute little guy,” one person commented online. 

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“Such a precious baby,” another person wrote. 

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ChatGPT could miss your serious medical emergency, new study suggests

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ChatGPT could miss your serious medical emergency, new study suggests

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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice.

In January, OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool. 

The company introduced the tool as “a dedicated experience that securely brings your health information and ChatGPT’s intelligence together, to help you feel more informed, prepared and confident navigating your health.”

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But researchers at the Icahn School of Medicine at Mount Sinai have found that the tool failed to recommend emergency care for a “significant number” of serious medical cases.

The study, published in the journal Nature Medicine on Feb. 23, aimed to explore how ChatGPT Health — which is reported to have about 40 million users daily — handles situations where people are asking whether to seek emergency care.

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice. (iStock)

“Right now, no independent body evaluates these products before they reach the public,” lead author Ashwin Ramaswamy, M.D., instructor of urology at the Icahn School of Medicine at Mount Sinai in New York City, told Fox News Digital.

“We wouldn’t accept that for a medication or a medical device, and we shouldn’t accept it for a product that tens of millions of people are using to make health decisions.”

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Emergency scenarios

The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies.

Three independent physicians then assigned an appropriate level of urgency for each case, based on published clinical practice guidelines in 56 medical societies.

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The researchers conducted 960 interactions with ChatGPT Health to see how the tool responded, taking into account gender, race, barriers to care and “social dynamics.”

While “clear-cut emergencies” — such as stroke or severe allergy — were generally handled well, the researchers found that the tool “under-triaged” many urgent medical issues.  

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The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies. (iStock)

For example, in one asthma scenario, the system acknowledged that the patient was showing early signs of respiratory failure — but still recommended waiting instead of seeking emergency care.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum — the cases where getting it right matters most,” Ramaswamy told Fox News Digital. “It under-triaged over half of genuine emergencies and over-triaged roughly two-thirds of mild cases that clinical guidelines say should be managed at home.”

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Under-triage can be life-threatening, the doctor noted, while over-triage can overwhelm emergency departments and delay care for those in real need.

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Researchers also identified inconsistencies in suicide risk alerts. In some cases, it directed users to the 988 Suicide and Crisis Lifeline in lower-risk scenarios, and in others, it failed to offer that recommendation even when a person discussed suicidal ideations.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum.”

“The suicide guardrail failure was the most alarming,” study co-author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, told Fox News Digital.

ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm, the researcher noted.

OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool, in January 2026. (Gabby Jones/Bloomberg via Getty Images)

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“We tested it with a 27-year-old patient who said he’d been thinking about taking a lot of pills,” Nadkarni said. “When he described his symptoms alone, the banner appeared 100% of the time. Then we added normal lab results — same patient, same words, same severity — and the banner vanished.” 

“A safety feature that works perfectly in one context and completely fails in a nearly identical context … is a fundamental safety problem.”

CHATGPT HEALTH PROMISES PRIVACY FOR HEALTH CONVERSATIONS

The researchers were also surprised by the social influence aspect.

“When a family member in the scenario said ‘it’s nothing serious’ — which happens all the time in real life — the system became nearly 12 times more likely to downplay the patient’s symptoms,” Nadkarni said. “Everyone has a spouse or parent who tells them they’re overreacting. The AI shouldn’t be agreeing with them during a potential emergency.”

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Fox News Digital reached out to Open AI, creator of ChatGPT, requesting comment.

Physicians react

Dr. Marc Siegel, Fox News senior medical analyst, called the new study “important.” 

“It underlines the principle that while large language models can triage clear-cut emergencies, they have much more trouble with nuanced situations,” Siegel, who was not involved in the study, told Fox News Digital. 

ChatGPT and other LLMs can be helpful tools, a doctor said, but they “should not be used to give medical direction.” (iStock)

“This is where doctors and clinical judgment come in — knowing the nuances of a patient’s history and how they report symptoms and their approach to health.”

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ChatGPT and other LLMs can be helpful tools, Siegel said, but they “should not be used to give medical direction.”

“Machine learning and continued input of data can help, but will never compensate for the essential problem – human judgment is needed to decide whether something is a true emergency or not.”

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Dr. Harvey Castro, an emergency physician and AI expert in Texas, echoed the importance of the study, calling it “exactly the kind of independent safety evaluation we need.”

“Innovation moves fast. Oversight has to move just as fast,” Castro, who also did not work on the study, told Fox News Digital. “In healthcare, the most dangerous mistakes happen at the extremes, when something looks mild but is actually catastrophic. That’s where clinical judgment matters most, and where AI must be stress-tested.”

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Study limitations

The researchers acknowledged some potential limitations in the study design.

“We used physician-written clinical scenarios rather than real patient conversations, and we tested at a single point in time — these systems update frequently, so performance may change,” Ramaswamy told Fox News Digital.

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Additionally, most of the missed emergencies happened in situations where the danger depended on how the condition was changing over time. It’s not clear whether the same problem would happen with acute medical emergencies.

Because the system had to choose just one fixed urgency category, the test may not reflect the more nuanced advice it might give in a back-and-forth conversation, the researchers noted. 

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ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm. (iStock)

Also, the study wasn’t large enough to confidently detect small differences in how recommendations might vary by race or gender.

“We need continuous auditing, not one-time studies,” Castro noted. “These systems update frequently, so evaluation must be ongoing.”

‘Don’t wait’

The researchers emphasized the importance of seeking immediate care for serious issues.

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“If something feels seriously wrong — chest pain, difficulty breathing, a severe allergic reaction, thoughts of self-harm — go to the emergency department or call 988,” Ramaswamy advised. “Don’t wait for an AI to tell you it’s OK.”

The researchers noted that they support the use of AI to improve healthcare access, and that they didn’t conduct the study to “tear down the technology.”

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“These tools can be genuinely useful for the right things — understanding a diagnosis you’ve already received, looking up what your medications do and their side effects, or getting answers to questions that didn’t get fully addressed in a short doctor’s visit,” Ramaswamy said. 

“That’s a very different use case from deciding whether you need emergency care. Treat them as a complement to your doctor, not a replacement.”

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“This study doesn’t mean we abandon AI in healthcare.”

Castro agreed that the benefits of AI health tools should be weighed against the risks.

“AI health tools can increase access, reduce unnecessary visits and empower patients with information,” he said. “They are not inherently unsafe, but they are not yet substitutes for clinical judgment.”

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“This study doesn’t mean we abandon AI in healthcare,” he went on. “It means we mature it. Independent testing and stronger guardrails will determine whether AI becomes a safety net or a liability.”

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