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First AI-generated drug enters human clinical trials, targeting chronic lung disease patients

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First AI-generated drug enters human clinical trials, targeting chronic lung disease patients

The first-ever drug generated by artificial intelligence has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced yesterday.

The drug, currently referred to as INS018_055, is being tested to treat idiopathic pulmonary fibrosis (IPF), a rare, progressive type of chronic lung disease

The 12-week trial will include participants diagnosed with IPF.

“This drug, which will be given orally, will undergo the same rigorous testing to ensure its effectiveness and safety, like traditionally discovered drugs, but the process of its discovery and design are incredibly new,” said Insilico Medicine’s CEO Alex Zhavoronkov, PhD, in a statement to Fox News Digital.

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“However, with the latest advances in artificial intelligence, it was developed much faster than traditional drugs.”

How AI is transforming drug discovery

For any new drug, there are four steps, explained Zhavoronkov, who is based in Dubai.

“First, scientists have to find a ‘target,’ a biological mechanism that is driving the disease, usually because it is not functioning as intended,” he said.

Insilico Medicine’s CEO Alex Zhavoronkov, PhD (left), is pictured in the company’s AI-run robotics lab in Suzhou, China, which Insilico opened in January 2023.  (Insilico Medicine)

“Second, they need to create a new drug for that target, similar to a puzzle piece, that would block the progression of the disease without harming the patient.” 

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The third step is to conduct studies — first in animals, then in clinical trials in healthy human volunteers, and finally in patients.

RESEARCHERS USE AI TO UNDERSTAND ALZHEIMER’S DISEASE, IDENTIFY DRUG TARGETS

“If those tests show positive results in helping patients, the drug reaches its fourth and final step — approval by the regulatory agencies for use as a treatment for that disease,” said Zhavoronkov.

In the traditional process, he said, scientists find targets by combing through scientific literature and public health databases to look for pathways or genes linked to diseases. 

Insilico Medicine lab

CEO Alex Zhavoronkov, PhD (left), in the company’s AI-run robotics lab in Suzhou, China. “AI allows us to analyze massive quantities of data and find connections that human scientists might miss,” he said, “and then ‘imagine’ entirely new molecules that can be turned into drugs.” (Insilico Medicine)

“AI allows us to analyze massive quantities of data and find connections that human scientists might miss, and then ‘imagine’ entirely new molecules that can be turned into drugs,” Zhavoronkov said.

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In this case, Insilico used AI both to discover a new target for IPF and then to generate a new molecule that could act on that target. 

AI TECH AIMS TO HELP PATIENTS CATCH DISEASE EARLY, EVEN ‘REVERSE THEIR BIOLOGICAL AGE’

The company uses a program called PandaOmics to detect disease-causing targets by analyzing scientific data from clinical trials and public databases.

Once the target was discovered, researchers entered it into Insilico’s other tool, Chemistry42, which uses generative AI to design new molecules.

Insilico Medicine AI lab

The first drug generated by artificial intelligence has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced. (Insilico Medicine)

“Essentially, our scientists provided Chemistry42 with the specific characteristics they were looking for and the system generated a series of possible molecules, ranked based on their likelihood of success,” Zhavoronkov said. 

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The chosen molecule, INS018_055, is so named because it was the 55th molecule in the series and showed the most promising activity, he said.

AI-DISCOVERED DRUG SHOWS ‘ENORMOUS POTENTIAL’ TO TREAT SCHIZOPHRENIA: ‘REAL NEED FOR BETTER TREATMENT’

The current treatments for idiopathic pulmonary fibrosis are pirfenidone and nintedanib. 

While these drugs may provide some relief or slow the worsening of symptoms, they do not reverse the damage or stop progression, Zhavoronkov said. 

Insilico Medicine AI lab

The Insilico team is hopeful the data from this newly launched clinical trial will confirm their drug’s safety and effectiveness. (Insilico Medicine)

They also have unpleasant side effects, most notably nausea, diarrhea, weight loss and loss of appetite.

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“There are very few options for people with this terrible condition, and the prognosis is poor — most will die within two to five years of diagnosis,” Zhavoronkov explained.

“Our initial studies have indicated that INS018_055 has the potential to address some of the limitations of current therapies.”

Next steps

The Insilico team is hopeful the data from this newly launched clinical trial will confirm the drug’s safety and effectiveness.

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“If our Phase IIa study is successful, the drug will then go to Phase IIb with a larger cohort of participants,” said Hong Kong-based Sujata Rao, M.D., Insilico’s chief medical officer, in a statement to Fox News Digital. 

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During Phase IIb, the primary objective will be to determine whether there is significant response to the drug, Rao said.

Insilico Medicine AI lab

In this case, Insilico used AI to discover a new target for IPF — and then to generate a new molecule that could act on that target.  (Insilico Medicine)

“Then, the drug will go on to be evaluated in a much larger group of patients — typically hundreds — in Phase III studies to confirm the safety and effectiveness before it can be approved by the FDA as a new treatment for patients with that condition,” he explained.

One of the biggest challenges with these trials is recruiting patients, Rao said, particularly for a rare disease like idiopathic pulmonary fibrosis. 

“Patients need to fulfill certain criteria in order to be considered for trial enrollment,” he noted. 

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Despite the challenges, Rao said the research team is optimistic that this drug will be ready to go to market — and reach the patients who may benefit from it — in the next few years.

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Life after death: Take a glimpse into the world of cryonics

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Life after death: Take a glimpse into the world of cryonics

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Since the age of 13, Joseph Kowalsky has harbored a fascination with life after death, pondering ways to extend his existence indefinitely. 

Today, Kowalsky, now 59, is among some 2,000 individuals who have signed up with the Cryonics Institute in Clinton Township, Michigan, betting on a future where death is not the end.

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Chilling prospect of immortality

Cryonics, the process at the heart of Kowalsky’s hopes, involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them. 

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Shortly after a person dies, organizations like the Cryonics Institute use a heart-lung resuscitator, circulate a medical-grade antifreeze in the blood and suspend the body in aluminum pods filled with liquid nitrogen. 

Dennis Kowalski, current president of the Cryonics Institute (and no relation to Joseph Kowalsky), told Fox News that over 250 individuals are currently in “suspension” at the Michigan facility.

Cryonics involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them.  (Cryonics Institute)

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Could defying death be affordable?

The Cryonics Institute is just one player in a burgeoning industry. 

Alcor, the world’s oldest cryonics company, which is based in Scottsdale, Arizona, boasts a state-of-the-art facility where more than 200 individuals are preserved. 

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For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000. 

Alcor CEO James Arrowood dispels the notion that cryonics is solely for the wealthy, highlighting that many clients use life insurance policies to cover costs. 

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Cryonics Institute

Over 250 individuals are currently in “suspension” at the Michigan facility, the president of the Cryonics Institute told Fox News. (Cryonics Institute)

“About 80% of people who sign up are middle-class,” Arrowood told Fox News.

He pointed out that the clientele includes notable figures such as baseball legend Ted Williams, whose head and body were cryopreserved separately.

Skeptics cast doubt

Critics dismiss cryonics as speculative and unproven, labeling it an “iceberg scheme” lacking scientific backing. 

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“It’s a sad case of people being beguiled by a very understandable dream of resurrection,” Clive Coen of King’s College London told Fox News.

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The neuroscience professor raised concerns over the damage inflicted during the preservation and revival process, warning that “there will be billions of mini-strokes in every millimeter of brain tissue” due to the inability of antifreeze to traverse the brain’s complex landscape.

Hope springs eternal for death defiers

There is currently no scientific evidence or successful case of a human being revived from a cryonically preserved state. 

Cryonics Institute

For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000.  (Cryonics Institute)

Despite the skepticism, Joseph Kowalsky, who formerly worked with the Cryonics Institute, remains undeterred. 

“Worst-case scenario, I’m still dead … And the upside? It could be a potentially life-saving medical technique,” he said.

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As science and ethics continue to grapple with the implications of cryonics, individuals like Kowalsky illustrate a deep-seated hope for defying mortality, one frozen body at a time.

Andres del Aguila and Griff Jenkins contributed to this report.

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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Most of the 38 million people living with diabetes in the U.S. use daily injections or insulin pumps to keep glucose at safe levels — but new research suggests that a third option could be just as effective.

In a study led by Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, an inhaled form of insulin — similar to an asthma inhaler — worked just as well as injections or pumps to control type 1 diabetes.

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The research was presented last week at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, Florida.

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The clinical trial tested a product called Afrezza, an inhaled insulin made by MannKind Corporation in California. 

Afrezza, the only inhaled insulin on the market, has been available since getting FDA approval in June 2014.

An inhaled form of insulin worked just as well as injections or pumps to control type 1 diabetes in a recent study. (iStock/MannKind)

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Benefits of a third option

“In those with type 1 diabetes, insulin is required for survival,” Hirsch told Fox News Digital in an interview. 

“With continuous glucose sensing, glucose control has been dramatically improved — but not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” he said.

EATING ONE TYPE OF FRUIT REGULARLY COULD REDUCE DIABETES RISK IN WOMEN, STUDY SUGGESTS: ‘INCREDIBLY HEALTHY’

With pumps, people must wear the device, which can lead to skin problems

They also have to purchase extra accessories.

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Blood glucose levels can also drop with exercise, Hirsch warned, which can be problematic. 

Afrezza inhaler

Afrezza, an inhaled insulin pictured here, is made by MannKind Corporation in California.  (MannKind)

“Injections overall can be more convenient for some, but they don’t do as well as pump patients,” he said.

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, Hirsch noted.

“Patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice.”

During the 17-week study, researchers evaluated the results of 141 adults who were assigned to either use the Afrezza inhaler or continue with traditional methods of injection or pump delivery.

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At the 17-week mark, all participants switched to the inhaler for another 13 weeks.

Dr. Irl B. Hirsch

Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, led the new study. (MannKind)

All groups were assessed with continuous glucose monitoring at the start of the study, at 17 weeks and again at 30 weeks.

Among the inhaled insulin group, 30% of participants reached their target glucose levels (less than 7% blood sugar) compared to 17% of the people using injections and pumps.

There was no difference in hypoglycemia (low blood sugar) between the groups.

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“In general, there was no difference in our primary endpoint, HbA1c, a reflection of average blood sugar,” Hirsch said. 

“But that alone is misleading — many patients did better with their glucose control, while others did worse.”

Afrezza inhaler

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, a doctor said. (MannKind)

“The point is, inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

The people who saw the best results inhaled insulin between meals and at bedtime, Hirsch added.

                             

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At the end of the study, more than half of the participants said they would opt to stay on the inhaled insulin therapy.

“The biggest takeaway is that patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice,” he recommended.

‘Adds value’

The American Diabetes Association acknowledged the promise of the study findings in an email to Fox News Digital.

“We look forward to our Scientific Sessions every year to see data like the INHALE-3 study’s findings, which have the potential to expand diabetes care,” Raveendhara Bannuru, M.D., PhD, the ADA’s vice president of medical affairs and quality improvement outcomes in Boston, Massachusetts, told Fox News Digital via email.

diabetes CGM

“With continuous glucose sensing, glucose control has been dramatically improved,” a doctor told Fox News Digital. (iStock)

“We are hopeful for the continuous development of alternative insulin delivery methods that could offer options for people living with diabetes,” the group also said in the statement.

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“The INHALE-3 trial demonstrated that inhaled insulin, combined with insulin degludec, effectively reduces A1c levels without increasing hypoglycemia or weight gain in people with type 1 diabetes. This adds value to the options in insulin therapy.”

Potential risks and limitations

While more people met their glycemic targets with Afrezza, some subjects saw worse readings when switching from usual methods to inhaled insulin — “potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime,” the researchers wrote.

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“We didn’t see any concerns,” Hirsch said when asked about side effects. 

“As expected, a few people coughed immediately when dosing their insulin, but no major concerns were seen and everyone continued on their inhaled insulin.”

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Insulin injection

“Not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” a doctor said. (iStock)

The most common side effects noted in the study were hypoglycemia, cough and throat pain or irritation. 

Afrezza has been linked to a risk of acute bronchospasm in patients with chronic lung disease, such as asthma or COPD, according to the manufacturer.

“Inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

Before starting Afrezza, patients should see a doctor for a physical examination and testing to measure lung function.

Patients who smoke or who recently quit smoking should not take the inhaled medication.

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Fox News Digital reached out to MannKind requesting additional comment.

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