May 24, 2024

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The world’s first AI-generated drug enters human clinical trials

The world’s first AI-generated drug enters human clinical trials


The world’s first AI-generated drug enters human clinical trials

News on June 30, this week, the world’s first drug designed entirely by artificial intelligence entered the human clinical trial stage.

The drug, called INS018_055, is being developed by Hong Kong-based biotech startup Insilo Medicine for the treatment of idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a chronic disease that causes scarring in the lungs.


The prevalence of the disease has increased in recent decades and currently affects about 100,000 people in the United States, according to the National Institutes of Health. If left untreated, patients can die within two to five years.


Alex Zhavoronkov, founder and CEO of Insilo Medicine, said: “This is the first drug designed entirely by generative artificial intelligence to enter human clinical trials.

Phase 2 trials are already underway in patients. While there are other AI-designed drugs in trials, our drug targets novel targets discovered by AI and was designed with AI in mind.”


Zavoronkov said the discovery process for the new drug began in 2020 with the goal of creating a “moonshot (crazy or unlikely project)” drug to overcome current challenges in treating the disease. Current treatments focus on slowing the progression of the disease and can cause uncomfortable side effects.


The world's first AI-generated drug enters human clinical trials



He added that he chose to focus on IPF in part because of the disease’s impact on aging.

The company has two other drugs, designed in part with the help of artificial intelligence, also in clinical stages. One is a COVID-19 pneumonia drug that is undergoing phase 1 clinical trials, and the other is an anti-cancer drug that can be used as a “USP1 inhibitor for the treatment of solid tumors”, which was recently approved by the US Food and Drug Administration (FDA), Clinical trials can begin.


Insilo Medicine is currently conducting a 12-week randomized, double-blind, placebo-controlled trial of INS018_055 in China, and the company plans to expand the trial population to 60 subjects at 40 sites in the U.S. and China.

If the Phase 2 study is successful, the company will move on to another, larger study before potentially moving into a Phase 3 study with several hundred participants.


“We expect to have results from the current phase 2 trial next year,” Zavoronkov said, adding that it is difficult to predict the exact timing of future trials, especially given that the disease is relatively rare and patients must meet certain criteria






(source:internet, reference only)

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