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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As winter weather moves in, cozy essentials like scarves, plush throws and heated bedding become everyday comforts.
But dermatologists caution that these cold-weather favorites can secretly undermine skin health — trapping sweat and bacteria, causing irritation and exposing the skin to excess heat.
Choosing the right materials for wellness — and using them safely — can make a big difference.
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Here are five winter must-haves and gift ideas, with expert tips on how to keep skin healthy and happy while staying warm this season.
Soft scarf, $19.99, Amazon.com
Scarves made of natural fiber, like this one that is 100% cotton, may help if you’re prone to irritation. (Amazon)
A soft scarf is a staple for cold days and an easy way to elevate a winter outfit.
Yet, if breakouts are appearing along the neck, jawline or chest, that favorite accessory may be part of the problem.
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“You should wash your scarf as often as your clothes to prevent breakouts,” Annabelle Taurua, a beauty expert at Fresha, a beauty and wellness booking platform headquartered in London, told Fox News Digital.
Cotton is a better choice than polyester, she also noted, as it’s more breathable and allows sweat to evaporate.
Fluffy blankets, $28.97, Potterybarn.com
Fluffy blankets make for perfect cozy days at home, but their soft fibers can trap sweat, oils and dead skin — which can clog pores and encourage bacteria growth. (Pottery Barn)
Fluffy blankets make for perfect cozy days at home, but their soft fibers can trap sweat, oils and dead skin, which can clog pores and encourage bacteria growth.
Rough textures or infrequent washing can also irritate sensitive skin and worsen breakouts.
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“Regularly wash your blankets, especially those made from synthetic or fluffy materials, to remove built-up oils and dirt,” Taurua advised.
She recommended breathable materials like cotton or linen, as well as hypoallergenic options for anyone prone to irritation.
Good set of sheets, $49.99, Amazon.com
Much like scarves, natural fibers are the way to go for your linens to avoid irritation. (iStock)
Cold weather makes lingering in bed especially tempting, but lying on unwashed bedding can worsen acne.
Pillowcases and sheets quickly collect oil, bacteria and dead skin cells, which transfer directly onto the face.
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“Washing bedding frequently is important,” Taurua said. “You should aim to change and wash your pillowcases every two to three days and your sheets at least once a week.”
Heated blanket, $33.99, Walmart.com
Heated blankets are a great way to stay warm during the winter. (Walmart)
When using a heated blanket, start with the lowest heat setting and limit use, said Taurua.
“Once you’re warm, switch to a regular blanket,” she advised.
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She also said it’s best to avoid direct contact for long periods to reduce irritation.
Hot water bottle, $12.99, Amazon.com
A traditional winter staple, hot water bottles offer quick comfort — but they come with risks similar to heated blankets, including burns, scalding and long-term heat-related skin damage.
Hot water bottles should never be filled with boiling water, experts advise. (Amazon)
“Never fill a hot water bottle with boiling water,” Taurua said.
“Only use hot, not boiling, water, and fill it to a maximum of two-thirds.”
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She recommended wrapping the bottle in a towel or cover to avoid direct skin contact and limiting use to around 20 minutes.
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Comedian Amy Schumer, 44, has recently come clean about her struggle with Cushing’s syndrome, leading to a dramatic weight loss.
Schumer’s transformation has sparked conversation online, to which she responded in a now-deleted Instagram post that shut down speculation about cosmetic enhancements.
“I didn’t lose 30lbs — I lost 50,” she emphasized on social media, adding that she does not get Botox or filler.
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Schumer doubled down that her weight loss was not about her appearance, but about staying alive.
“Not to look hot, which does feel fun and temporary,” she said. “I did it to survive. I had a disease that makes your face extremely puffy that can kill you, but the internet caught it and that disease has cleared.”
Amy Schumer attends Variety’s 2024 Power of Women: New York event on May 2, 2024, in New York City on the left. On the right, Schumer later poses for a photo posted to Instagram after her weight loss. (Marleen Moise/WireImage; Amy Schumer/Instagram)
“Sorry for whatever feeling it’s giving you that I lost that weight,” she added. “I’ve had plastic surgery over the years and I use [Mounjaro]. Sorry to anyone they let down. I’m pain free. I can [play] tag with my son.”
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The actress also addressed her shifting hormones, saying that she’s “happy to share more if anyone has any questions about how I’m looking or feeling or where I am in my perimenopause process.”
“I didn’t lose 30lbs — I lost 50,” Schumer emphasized on social media, adding that she does not get Botox or filler. (Amy Schumer/Instagram)
What is Cushing’s syndrome?
Schumer previously revealed that she had been diagnosed with Cushing’s syndrome, a hormonal disorder that can cause extreme swelling, fatigue and potentially fatal complications.
Dr. Peter Balazs, a hormone and weight loss specialist in New Jersey, provided more details on the condition in an interview with Fox News Digital.
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“Cushing’s syndrome is caused by prolonged, high exposure to cortisol, which is your body’s main stress hormone,” he said. “Usually, the excess cortisol is a result of prolonged steroid use. We see this many times with patients who have some autoimmune disorder.”
Balazs said the “key” to Cushing’s syndrome is not just weight gain, but a “specific redistribution” of fat caused by too much cortisol.
Amy Schumer is photographed during a guest interview on The Tonight Show Starring Jimmy Fallon on Feb. 13, 2024 (left), and later seen walking through midtown New York City on Oct. 28, 2025 (right). (Todd Owyoung/NBC via Getty Images; Raymond Hall/GC Images/Getty Images)
Fat may be driven to the abdomen, chest, upper back (referred to as a “buffalo hump”) or face, sometimes considered “moon face,” the doctor said.
Cortisol also breaks down protein, which leads to a thinning in the arms and legs. “Weight gain can be tough, involuntary and hard to manage,” Balazs added.
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Cortisol stimulates “hunger centers” in the brain, raises blood sugar and promotes fat storage, especially deep belly fat, according to the doctor.
Cushing’s syndrome can also cause high blood pressure, bone loss and sometimes type 2 diabetes, per Mayo Clinic.
In addition to weight gain in certain areas, other symptoms may include pink or purple stretch marks on the stomach, hips, thighs, breasts and underarms, as well as acne, slow wound healing, and thin, frail skin that bruises easily.
With Cushing’s syndrome, fat may accumulate in the abdomen, chest, face or upper back (referred to as a “buffalo hump”). (iStock)
Women with Cushing’s syndrome often experience thick, dark hair on the face and body, as well as irregular periods. Symptoms among men can include a lower sex drive, reduced fertility and erectile dysfunction.
Mayo Clinic listed other potential symptoms, including extreme fatigue, muscle weakness, depression, anxiety, irritability, mood swings, trouble with concentration and memory, headache, sleeplessness, skin darkening and stunted growth in children.
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Those with symptoms should contact their doctor immediately, especially if they are taking steroids to treat health issues like asthma, arthritis or inflammatory bowel disease, as these medications can exacerbate the condition.
The Mayo Clinic has reported that the “sooner treatment starts, the better the chances for recovery.”
“I’ve had plastic surgery over the years and I use [Mounjaro],” Schumer stated in a social media post. (George Frey/Bloomberg)
For patients like Schumer, weight loss is typically not the main goal, Balazs noted, but it is a “critical sign” of successful treatment.
“The primary goal is to normalize your high cortisol levels,” he said. “I believe Amy Schumer got treated first for her underlying problem. Once the cortisol is normalized, which is the most important step, there’s a role to use adjunct medications to decrease weight.”
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Among GLP-1s, Mounjaro is an “excellent choice to decrease deep belly fat and increase insulin sensitivity of cells,” Balazs added.
Fox News Digital’s Stephanie Giang-Paunon contributed to this report.
Fox News Digital reached out to Schumer’s rep requesting comment.
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