In a first, a drug discovered and designed using artificial intelligence (AI) for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic disease that causes scarring in the lungs, has entered human clinical trials.

Hong Kong-based biotechnology company Insilico Medicine, in a statement, announced that the Phase II trial on oral dosage of INS018_055 is currently being conducted for over 12 weeks in China, and will later be expanded to test 60 people in the US and China.

Once successful, the company aims to study a larger cohort. "With demonstrated potential against both fibrosis and inflammation, INS018_055 could offer another option for patients worldwide," said Feng Ren, co-CEO and Chief Scientific Officer of Insilico Medicine, in the statement.

"Initiating Phase II trials with this novel inhibitor for IPF represents a major milestone for deep generative reinforcement learning in drug discovery. We will explore the efficacy for patients of AI-discovered and designed treatments in clinical trials, which is a true validation of our generative AI platform", added Alex Zhavoronkov, Founder and co-CEO of Insilico Medicine.

Zhavoronkov said the discovery process for the new drug began in 2020, with hopes to create a “moonshot” medicine to overcome challenges with current treatments for the condition, which mostly focus on slowing progression and can cause uncomfortable side effects, CNBC reported.

He added that the company has two other drugs partially generated by AI in the clinical stage. One is a COVID-19 drug in phase one clinical trials, and the other is a cancer drug, specifically a “USP1 inhibitor for the treatment of solid tumours”, that recently received FDA approval to initiate clinical trials.

Zhavoronkov said he expects to have results from the current Phase II trial next year.

IPF affects the tissue surrounding the air sacs, or alveoli, in the lungs. It develops when that lung tissue becomes thick and stiff for unknown reasons. Over time, these changes can cause permanent scarring in the lungs, called fibrosis, that makes it progressively more difficult to breathe.

The condition worsens with age and if left untreated, can lead to death within two to five years.