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The world’s first drug entirely created by AI has entered the human trial phase

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The world’s first drug entirely created by AI has entered the human trial phase

It may help patients with idiopathic fibrosing alveolitis.

This week started clinical trials of the world’s first drug entirely created by artificial intelligence. The drug, dubbed INS018_055, was developed by a Hong Kong biotech company. Insilico Medicine, which has attracted over $400 million in investment. The medicine is intended for the treatment of idiopathic fibrosing alveolitis (IPF) – a chronic disease that causes scarring of the lungs. The condition, which has increased in frequency in recent decades, currently affects about 100,000 people in the US and can lead to death within two to five years if left untreated, according to the National Institutes of Health.

“This is the first fully generative AI-based drug to reach human clinical trials, and specifically phase II patient trials,” said Alex Zhavoronkov, founder and CEO of Insilico Medicine. “Our drug is the first drug with a new target discovered by AI and a new design created by AI.”

He added that the company has two more drugs, partially created with the help of AI, that are in clinical trials. One is a Covid-19 drug in Phase 1 clinical trials, and the other is a cancer drug, the “USP1 Inhibitor for Solid Tumors,” which recently received FDA approval to begin clinical trials.

The current IPF drug trial is a 12-week, double-blind, randomized, placebo-controlled trial in China, and Insilico plans to expand the trial population to 60 subjects at 40 sites in the US and China. If the current Phase 2 trial is successful, it will move on to another study with a larger cohort and then potentially reach a Phase 3 trial with hundreds of participants.

“We expect to have results from the current phase two trial next year,” Zhavoronkov said, adding that it is difficult to predict the exact timing for future phases, especially given that the disease is relatively rare and patients must meet certain criteria. He added: “We are optimistic that this drug will be ready to market and reach patients who can benefit from it in the next few years.”



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