Clinical-stage biotechnology company Insilico Medicine (HKEX:3696) announced on Wednesday that it has dosed the first patient with rentosertib (known as ISM001-055 / INS018_055) in GENESIS-IPF-3, a Phase III clinical trial at Peking Union Medical College Hospital, while Shanghai Pulmonary Hospital has also enrolled its first patient on the same day.

The prospective, multi-centre, randomised, double-blind, placebo-controlled, parallel-group study is designed to systematically evaluate the efficacy and safety of once-daily rentosertib administered over 52 weeks.

Preliminary findings in the 12-week Phase IIa study showed promising results, including improvements in lung function among patients with idiopathic pulmonary fibrosis (IPF). The Phase III study is designed to validate the Phase IIa findings in a larger cohort of IPF patients treated for a longer duration of 52 weeks.

"From initiating Phase III to obtaining final regulatory approval, it will take three to four years under favourable conditions," said Professor Zuojun Xu of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, the leading principal investigator of the study.

According to Insilico, rentosertib is the world's first drug candidate discovered and developed using generative AI which has advanced to a Phase III trial.