Hong Kong-based artificial intelligence (AI)-powered drug discovery company Insilico Medicine has completed administering the first dose of its AI-discovered drug in a Phase II clinical trial. The move marked the world's first small molecule drug designed by AI that has entered the clinical stage, opening up a vast market potential.
Insilico Medicine revealed INS018_055, a treatment of idiopathic pulmonary fibrosis (IPF), a chronic progressive and irreversible lung disease. The drug was selected and designed using generative AI, which goes beyond simple data analysis and involves learning and deduction based on existing data.
The randomised, double-blind, placebo-controlled, clinical trial will assess the safety, tolerability, pharmacokinetics (PKs), and preliminary efficacy of a 12-week oral dosage of INS018_055 in patients with IPF. This trial will have four cohorts, with patients receiving 30mg once-daily (QD), 30mg twice-daily (BID), 60mg QD doses or placebo.
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Insilico plans to recruit 60 patients at 40 sites in China and US. The company initiated enrolment in China-based sites in April 2023 and received approval from the US Food and Drug Administration (FDA) for a simultaneous clinical trial in the US in June 2023.
Beyond the IPF indication, Insilico is advancing its AI-generated drugs in other diseases as well. In April, Insilico announced that it had discovered a potent selective and orally bioavailable small molecule inhibitor of cyclin-dependent kinase 8 (CDK8) to treat cancer.
According to clinicaltrialsarena.com & globaltimes.cn