Insilico Medicine founder and CEO Alex Zhavoronkov (left) and co-CEO and chief scientific officer Feng Ren at the company’s robotics lab in Suzhou, China.
Source: Insilico Medicine
The first drug generated entirely by artificial intelligence entered clinical trials in human patients this week.
Insilico Medicine, a Hong Kong-based biotech startup with more than $400 million in funding, developed the drug, INS018_055, to treat idiopathic pulmonary fibrosis, a chronic disease that causes scarring of the lungs. The disease, which has increased in prevalence in recent decades and currently affects about 100,000 people in the United States, can cause death within two to five years if left untreated, according to the National Institutes of Health.
“This is the first fully generated AI drug to enter human clinical trials, specifically a Phase II trial in patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While there are other AI-designed drugs Trials are ongoing, but our drug is the first to have both new targets discovered by AI and new designs generated by AI.”
Zhavoronkov said the new drug discovery process began in 2020 with the hope of creating a “moon shot” drug to overcome current challenges in treating the disease, which mainly focuses on slowing disease progression and can cause uncomfortable symptoms. side effect.
He added that Insilico chose to focus on IPF in part because of the disease’s impact on aging, but the company has two other drugs, generated in part by artificial intelligence in the clinical stage. One is a Covid-19 drug in Phase I clinical trials, and the other is a cancer drug, specifically “USP1 Inhibitor for the Treatment of Solid Tumors,” which recently received FDA approval to start clinical trials.
“When this company was founded, we focused on algorithms — developing technologies that enable the discovery and design of new molecules,” Zavoronkov said. “In the early days, I never imagined that I would put my AI drug into clinical trials with patients. But we realized that in order to validate our AI platform, we would not only need to design new drugs for new targets, but also for Design new drugs for new targets. Put them into clinical trials to prove that our technology works.”
The current study of the IPF drug is a 12-week randomized, double-blind, placebo-controlled trial in China, and Insilico plans to expand the test population to 60 subjects at 40 sites in the United States and China. If the current phase 2 study is successful, it will move on to another study with a larger cohort and then potentially a phase 3 study with several hundred participants.
“We expect to have the results of the current phase 2 trial next year,” Zhavoronkov said, adding that it is difficult to predict the exact timing of future phases, especially because the disease is relatively rare and patients must meet certain criteria. He added: “We are optimistic that this drug will be ready to market within the next few years and reach patients who may benefit from it.”
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