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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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Want to age better? Researchers say 4-minute routine may help prevent dangerous falls

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Want to age better? Researchers say 4-minute routine may help prevent dangerous falls

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Just four minutes of daily strength exercises can dramatically improve mobility, balance and leg strength in older adults, per new research from the Penn State College of Medicine.

Standard public health guidelines recommend at least 150 minutes of moderate exercise per week. However, the study suggests that fewer than one in five older adults meet the recommended muscle-strengthening guidelines.

The research team designed a home-based program called Functional Activity Strength Training, or FAST-2. They evaluated 97 sedentary participants 65 and older, with an average age of 74.

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Before entering the study, these individuals were averaging just 18 minutes of total physical activity each week.

The older adults were randomly split into two groups, with one group performing the daily exercise routine and the other serving as a control group that received no intervention, according to the study’s press release.

Just four minutes of daily home strength training can significantly improve mobility, balance and leg strength in older adults, according to a Penn State College of Medicine study. (iStock)

Participants performed four basic movements for 30 seconds each, separated by 30-second rest intervals. The entire routine lasted exactly four minutes. The circuit consisted of push-ups, chair stands, two-arm resistance-band rows and stair stepping.

To keep the routine accessible, researchers provided written explanations and simple modifications. For example, participants could perform push-ups against a kitchen counter or wall, or use their hands on their knees for support during chair stands.

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Participants were also given four elastic resistance bands and an adjustable step platform.

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“Exercise is actually really complicated, because you have to decide how many repetitions, how far, how many sets, how much rest and how many times per week,” co-author Smita Dandekar, associate professor of pediatrics at Penn State College of Medicine, said in the press release.

“It’s hard work … so if we can make it short, we’re part [of the] way there.”

The program consisted of four basic movements: push-ups, chair stands, resistance-band rows and stair stepping. (iStock)

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As the participants grew stronger, they were encouraged to progress to higher levels of difficulty, such as transitioning away from modifications or increasing the height of the stepper.

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After 12 weeks, the results suggested that a tiny dose of regular exercise could yield noticeable physical benefits. In a 30-second chair-stand test, the exercise group performed an average of 4.2 more repetitions than the control group.

“These indicators … give you a sense of whether or not you’re going to be able to be active in the future.”

The adults doing the exercises also shaved 2.3 seconds off their time during a test measuring how they could stand up and sit down five times consecutively. Furthermore, they extended their one-legged balance time by an average of 3.6 seconds.

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The researchers emphasized that these specific measurements are critical medical indicators of an older adult’s future health.

By keeping the routine ultra-short, researchers eliminated common barriers like time constraints and exhaustion, resulting in an exceptionally high 81% workout completion rate. (iStock)

“These indicators predict your future ability to go into a nursing home, your future likelihood of falling and of developing difficulty walking,” noted lead author Christopher Sciamanna, professor of medicine and of public health at Penn State College of Medicine, in the press release.

“They give you a sense of whether or not you’re going to be able to be active in the future.”

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While traditional home exercise programs generally see low engagement, the participants in this study successfully completed their workouts on 81% of the tracked days, according to the researchers.

After 12 weeks, exercising seniors gained the ability to complete an average of four more chair-stand repetitions than those who did not exercise. (iStock)

The study had several noted limitations. As it tracked a relatively small sample size of fewer than 100 individuals over a brief 12-week time frame, it is unknown whether these mobility gains can be sustained long-term.

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Additionally, the researchers did not specify the exact dropout rates or detail how the routine might affect seniors who already relied on assistive devices like walkers or canes.

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Because the final trial results reflected a specific group of participants who met the entry criteria, further investigation is required to determine whether the short routine can safely benefit older adults facing more severe physical limitations or cognitive decline.

The study was published in the journal PLOS One.

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Popular mommy blogger dies at 48 two years after devastating cancer diagnosis

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Popular mommy blogger dies at 48 two years after devastating cancer diagnosis

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Jill Smokler, founder of Scary Mommy, has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer.

The popular “mommy blogger” had been fighting the disease for the past two years, according to an announcement posted on ScaryMommy.com on Monday.

The stay-at-home mother of three launched the blog in 2008 as a place to share the “joys and pitfalls” of parenting, according to the article.

As Scary Mommy expanded from a personal blog into a major parenting brand, Smokler built a following with her honest, often self-deprecating take on motherhood. She went on to speak at blogging conferences, author bestselling books, appear on national television programs and earn three Webby Awards, her biography states.

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“Jill spent her life telling the truth about motherhood — that it could be wonderful and impossible in the very same breath — and in doing so, she gave millions of women permission to stop pretending and feel a little less alone,” her family shared in a statement following her passing.

Jill Smokler, founder of Scary Mommy (pictured in 2018), has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer. (Lloyd Fox/Baltimore Sun/ZUMA Press Wire / Shutterstock)

“She was funny, fearless, generous and entirely herself. More than anything she built, Jill was proudest of her three children, Lily, Ben and Evan. We are heartbroken to lose her, and endlessly proud of the mark she left on the world.”

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Smokler’s first sign of the disease was in April 2024, when she experienced a sudden seizure. She then underwent surgery to remove a brain tumor, after which she didn’t recognize her own children, she previously shared with Today.

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“I am definitely grateful that I don’t remember the looks on their faces when I didn’t recognize them,” she said. “That must have been gutting.”

Smokler was diagnosed with glioblastoma, the most common malignant primary brain tumor in adults and one of the deadliest forms of brain cancer. There is currently no cure.

About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. (iStock)

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Following surgery, the blogger underwent radiation and chemotherapy, during which she was open about her treatment side effects, including fatigue and hair loss. Additional surgeries and clinical trials followed, according to previous interviews.

“Thank you, Jill, for everything. May you rest in peace,” the Scary Mommy post concluded.

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About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. More than 12,000 new cases are diagnosed in the U.S. each year.

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Median survival is approximately 12 to 18 months after diagnosis, even with treatment. Only about 5% to 7% of patients survive five years after diagnosis, data shows.

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8 common food preservatives linked to higher risk of high blood pressure and heart disease

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8 common food preservatives linked to higher risk of high blood pressure and heart disease

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Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study.

Researchers analyzed data from 112,395 adults averaging 42 years of age, assessing their detailed dietary intake with an average follow-up of nearly eight years.

Among the participants, 5,544 developed hypertension during the follow-up period, and 2,450 experienced cardiovascular disease events.

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Higher consumption of total non-antioxidant preservatives was associated with a 29% greater risk of hypertension and a 16% higher risk of cardiovascular disease.

Higher consumption of total antioxidant preservatives was linked to a 22% spike in hypertension risk.

Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study. (iStock)

Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension, including the following.

  • Potassium sorbate
  • Sorbic acid
  • Sodium nitrite
  • Potassium nitrite
  • Sodium metabisulphite
  • Potassium metabisulphite
  • Citric acid
  • Tripotassium citrate

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Only one of the preservatives – ascorbic acid, which is the food additive form of vitamin C – was significantly associated with higher cardiovascular disease risk.

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The finding does not mean that dietary vitamin C itself causes cardiovascular disease, the researchers noted. The study examined ascorbic acid in the form used as a food additive in processed foods, not vitamin C from fruits, vegetables or supplements.

Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension. (iStock)

The findings were published in the European Heart Journal.

“This is a very important study that puts together what we already know – that preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.

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“Whereas potassium itself can lower blood pressure, the additive potassium sorbate has previously been found to be associated with hypertension in a large study in the European Heart Journal,” the doctor, who was not involved in the study, told Fox News Digital. “Potassium metabisulphite was also found to raise pressure in the same study.”

The same was found for sodium nitrite in the new study, Siegel noted, with 73% of participants consuming it regularly – “mostly in processed foods like hot dogs, ham, bacon and deli meats.”

“Preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” a doctor told Fox News Digital. (iStock)

“This has been found in previous research for many years,” he added.

Siegel also discussed the 22% increased risk linked to ascorbic acid. “I am dubious about this association, as it has not generally been found before, but perhaps the risk is when it is used as a chemical preservative.”

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“For all the sodium additives, this is expected, but surprising with extracts of rosemary and citric acid – the key to both of these ingredients is when they are used as preservatives (chemicals),” he added.

Potential limitations

As this was an observational study, it could not prove that the additives caused the health conditions.

Also, the participants who volunteered for the study were generally healthier, more educated and more often female than the general French population, the researchers noted.

As this was an observational study, it could not prove that the additives caused the health conditions. (FG Trade / Getty Images)

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There was also the chance that hypertension was underdiagnosed in some participants.

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While the researchers estimated people’s dietary intake as accurately as possible, there was a chance that some consumption was inaccurately reported.

The authors emphasized that these findings need to be confirmed in further research of other populations.

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If the results are replicated in future research, some food preservatives may face additional safety reviews focused on their effects on the cardiovascular system, the researchers suggested.

“The take-home is to use natural ingredients as much as possible, and especially beware of sodium chemical preservatives when it comes to risk of heart disease and stroke from associated hypertension,” Siegel concluded.

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