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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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Diabetes surge among Americans could be driven by ‘healthy’ breakfasts, doctor warns

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Diabetes surge among Americans could be driven by ‘healthy’ breakfasts, doctor warns

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Americans consume foods every day that are marketed as “healthy,” when they could be quietly destroying their health, one doctor warns.

Dr. Mark Hyman, physician and co-founder of Function Health in California, says that much of America’s daily diet is filled with unhealthy ingredients.

“The amount of refined starches and sugars that are everywhere is just staggering to me, given what we know about how harmful they are,” he shared in an interview with Fox News Digital. “I don’t think people really understand.”

Hyman, author of the new book “Food Fix Uncensored,” said he’s “astounded” by what people are eating, especially for breakfast.

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“People just eat sugar for breakfast,” he said. “They have muffins, they have bagels, they have croissants, they have sugar-sweetened coffees and teas.”

Dr. Mark Hyman is the author of the new book “Food Fix Uncensored.” (Function Health; Little, Brown Spark)

In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products, following health trends that encourage eating more protein.

“Highly processed food is not food.”

“Now, we’re seeing this halo of protein in certain things,” Hyman said, mentioning that many protein smoothies are “full of sugar.”

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The doctor also noted that some popular cereals are now marketed as having protein in them. “My joke is, if it has a health claim on the label, it’s definitely bad for you,” he said.

Instead of starting the day with a “quick fix” or processed food, Hyman suggests choosing whole sources of protein and fat for breakfast, adding that “if there’s a little carbohydrate in there, it’s fine.”

More products marketed as “high protein” have cropped up on supermarket shelves. (iStock)

For his own breakfast, Hyman said he has a protein shake with whey protein, avocado and frozen berries. Eggs and avocados are also a great protein-and-fat combo option, he added.

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“It’s not that complicated — people need to just think about their breakfast not being dessert,” he said. “No wonder we’re in this cycle of obesity and diabetes. One in three teenage kids now has type 2 diabetes or pre-diabetes. That’s just criminal.”

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Instead of counting calories and being in a caloric deficit as a way to lose weight and stay healthy, Hyman instead suggests focusing on how certain foods make you feel and how they impact your health.

“When you look at the way in which different types of calories affect your biology, you can just choose what you’re eating, and then you don’t have to worry about how much,” he told Fox News Digital.

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In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products. (iStock)

“For example, if you eat a diet that doesn’t cause your insulin to spike — which is low in starch and sugar, higher in protein and fat — you won’t develop those swings in blood sugar, you won’t develop the spikes in insulin, you won’t deposit hungry fat … You will break that cycle.”

People are more likely to “self-regulate when they eat real food” instead of processed foods, which “bypasses the normal mechanisms of satiety, fullness and brain chemistry,” according to Hyman.

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“Ultraprocessed food and junk food or highly processed food is not food,” he said. “It doesn’t support the health and well-being of an organism. It doesn’t do that. It does the opposite.”

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Scientists make startling discovery when examining prostate cancer tissue

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Scientists make startling discovery when examining prostate cancer tissue

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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health. 

In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.

The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ. 

Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.

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In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)

The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.

Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.

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The scientists say this is the first direct evidence linking microplastics to prostate cancer.

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“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.

Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)

The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.

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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.

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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”

“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.

Study limitations

Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.

“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.

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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”

About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.

The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)

For those concerned about microplastics, Sidransky offered some insights.

“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.

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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”

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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.

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How a Vegan Diet Can Help You Lose Weight 8X Faster

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