Insilico Medicine has dosed the first patient in a Phase III clinical trial of rentosertib, an investigational idiopathic pulmonary fibrosis treatment that the company says was discovered and developed using generative artificial intelligence.
The patient was treated at Peking Union Medical College Hospital in China on Sept. 9. Shanghai Pulmonary Hospital also enrolled its first patient in the study that day, according to the company.
The GENESIS-IPF-3 trial is a prospective, randomized, double-blind, placebo-controlled study evaluating once-daily rentosertib over 52 weeks. The study is expected to enroll 320 patients at 47 centers in China.
Rentosertib is also known as ISM001-055 or INS018_055. The drug candidate targets TNIK, a protein that Insilico said had not previously been linked to fibrosis. The company said the program was discovered and developed using generative artificial intelligence.
The primary endpoint is the annual rate of decline in forced vital capacity, a measure of lung function, over 52 weeks. A key secondary endpoint is the time to a patient’s first disease-progression event.
The Phase III trial is intended to assess whether rentosertib provides clinical benefit in a larger patient population and over a longer treatment period than the Phase IIa study.
Insilico said earlier Phase IIa findings showed a dose-dependent efficacy trend and improvements in lung function among some patients. The company did not provide detailed Phase IIa data in the announcement.
The study is led by Zuojun Xu of Peking Union Medical College Hospital, with Nanshan Zhong of the Chinese Academy of Engineering and Chang Chen of Shanghai Pulmonary Hospital serving as co-leading principal investigators.
Rentosertib has not been approved by any regulatory authority. Results from the Phase III study will be needed to determine its efficacy and safety in patients with idiopathic pulmonary fibrosis.
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