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First AI-generated drug enters human clinical trials, targeting chronic lung disease patients

The first-ever drug generated by artificial intelligence has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced yesterday.

The drug, currently referred to as INS018_055, is being tested to treat idiopathic pulmonary fibrosis (IPF), a rare, progressive type of chronic lung disease

The 12-week trial will include participants diagnosed with IPF.

“This drug, which will be given orally, will undergo the same rigorous testing to ensure its effectiveness and safety, like traditionally discovered drugs, but the process of its discovery and design are incredibly new,” said Insilico Medicine’s CEO Alex Zhavoronkov, PhD, in a statement to Fox News Digital.

“First, scientists have to find a ‘target,’ a biological mechanism that is driving the disease, usually because it is not functioning as intended,” he said.

Insilico Medicine lab

Insilico Medicine’s CEO Alex Zhavoronkov, PhD (left), is pictured in the company’s AI-run robotics lab in Suzhou, China, which Insilico opened in January 2023.  (Insilico Medicine)

“Second, they need to create a new drug for that target, similar to a puzzle piece, that would block the progression of the disease without harming the patient.” 

The third step is to conduct studies — first in animals, then in clinical trials in healthy human volunteers, and finally in patients.

Insilico Medicine lab

CEO Alex Zhavoronkov, PhD (left), in the company’s AI-run robotics lab in Suzhou, China. “AI allows us to analyze massive quantities of data and find connections that human scientists might miss,” he said, “and then ‘imagine’ entirely new molecules that can be turned into drugs.” (Insilico Medicine)

“AI allows us to analyze massive quantities of data and find connections that human scientists might miss, and then ‘imagine’ entirely new molecules that can be turned into drugs,” Zhavoronkov said.

In this case, Insilico used AI both to discover a new target for IPF and then to generate a new molecule that could act on that target. 

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The chosen molecule, INS018_055, is so named because it was the 55th molecule in the series and showed the most promising activity, he said.

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The current treatments for idiopathic pulmonary fibrosis are pirfenidone and nintedanib. 

“Our initial studies have indicated that INS018_055 has the potential to address some of the limitations of current therapies.”

Next steps

The Insilico team is hopeful the data from this newly launched clinical trial will confirm the drug’s safety and effectiveness.

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One of the biggest challenges with these trials is recruiting patients, Rao said, particularly for a rare disease like idiopathic pulmonary fibrosis. 

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“Patients need to fulfill certain criteria in order to be considered for trial enrollment,” he noted. 

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