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Alex Zhavoronkov, left, founder and CEO of Insilico Medicine, and Feng Ren, co-CEO and chief scientific officer, at the company’s robotics lab in Suzhou, China.
Source: Insilico Medicine
The first drug created entirely by artificial intelligence entered clinical trials with human patients this week.
Insilico Medicine, a Hong Kong-based biotech startup with over $400 million in funding, created the drug INS018_055 as a treatment for idiopathic pulmonary fibrosis, a chronic disease that causes scarring in the lungs. This condition, which has increased in prevalence in recent decades, currently affects about 100,000 people in the United States and can lead to death within two to five years if not treated, according to the National Institutes of Health.
“It is the first fully generated AI drug to reach human clinical trials, specifically Phase II trials with patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While other AI-designed drugs are in trials, our drug is the first drug with a new AI-discovered target and an innovative AI-generated design.”
The process of discovering the new drug began in 2020, Zavoronkov said, with hopes of creating a “moonshot” drug to overcome challenges with current treatments for the condition, which focus mostly on slowing progression and can cause uncomfortable side effects.
He added that Insilico chose to focus on IPF in part because of the implications for the condition in aging, but that the company has two other partially AI-produced drugs in the clinical stage. One of them is a drug for Covid-19 that is in phase I clinical trials, and the other is a drug for cancer, specifically a “USP1 inhibitor for the treatment of solid tumors,” which recently received approval from the US Food and Drug Administration to start clinical trials.
“When this company launched, we were focused on algorithms — developing technology that could discover and design new molecules,” said Zahavoronkov. “I never imagined in those early days that I would be taking my 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 get it into clinical trials.” To prove the success of our technology.”
The current IPF study is a randomized, double-blind, placebo-controlled trial taking place over 12 weeks in China, and Insilico has plans to expand testing to 60 people at 40 sites in the United States and China. If the current study’s Phase 2 success is successful, it will move on to another study with a larger cohort, potentially all the way to Phase 3 studies with hundreds of participants.
“We expect to have results from the current phase II trial next year,” said Zahavoronkov, adding that it is difficult to predict the exact timing of future phases, especially since the disease is relatively rare and patients must meet specific criteria. He added, “We are optimistic that this drug will be ready to market, and reach patients who may benefit from it, in the next few years.”
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