Clinical trials for the first dose of drug developed fully by artificial intelligence (AI) has begun in human patients this week.
WASHINGTON — The first drug fully generated by artificial intelligence (AI) entered clinical trials with human patients this week.
Insilico Medicine, a biotechnology company based in Hong Kong with more than USD400 million in funding, announced that human patients have begun receiving the drug INS018_055, as a treatment for idiopathic pulmonary fibrosis (IPF), a chronic disease that causes scarring in the lungs.
The drug INS018_055, an anti-fibrotic small molecule inhibitor. are also used to prevent the formation of abnormal amounts of fibrous tissue that may grow in organs.
The condition, which has increased in prevalence in recent decades, currently affects about 100,000 people in the United States and about 5 million people worldwide and can lead to death within two to five years if untreated, according to the National Institutes of Health.
First Fully AI Drug To Reach Human Clinical Trials
“It is the first fully generative AI drug to reach human clinical trials, and specifically Phase II trials with patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC.
“While there are other Artificial Intelligence-designed drugs in trials, ours is the first drug with both a novel AI-discovered target and a novel AI-generated design.”
He added that Insilico has chosen to focus on IPF in part because of the condition’s implications in aging.
The company has two other drugs partially generated by AI in the clinical stage. One is a Covid-19 drug in phase one clinical trials, and the other is a cancer drug, specifically a “USP1 inhibitor for the treatment of solid tumors,” that recently received FDA approval to initiate clinical trials.
“When this company was launched, we were focused on algorithms — developing the technology that could discover and design new molecules,” Zhavoronkov said. “I never imagined in those early days that I would be taking my own AI drugs into clinical trials with patients. But we realized that in order to validate our AI platform, we needed to not only design a new drug for a new target, but bring it into clinical trials to prove that our technology worked.”
The IPF drug is being studied under a randomized, double-blind, placebo-controlled trial taking place over 12 weeks. It is being administered orally to patients in China.
Insilico intends to recruit 60 subjects with idiopathic pulmonary fibrosis to test the drug across 40 sites in the United States and China.
“We expect to have results from the current Phase II trial next year,” Zhavoronkov said, adding that it’s difficult to predict exact timing for future phases, especially since the disease is relatively rare and patients must fulfill specific criteria. He added, “We are optimistic that this drug will be ready for market, and reach patients who may benefit from it, in the next few years.
If the current phase two study is successful, it will go on to another study with a larger cohort, and then potentially reach phase three studies with hundreds of participants.
“With demonstrated potential against both fibrosis and inflammation, INS018_055 could offer another option for patients worldwide,” Feng Ren, co-CEO and chief scientific officer of Insilico Medicine said in a statement. — Media Hit