Sino Biopharm (01177) announced that the first patient has been enrolled in the Phase III clinical trial for its internally developed TDI01 "ROCK2 inhibitor," intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This milestone marks TDI01 as the world's first highly selective ROCK2 inhibitor to advance into Phase III clinical studies for IPF.
TDI01 is a novel ROCK2 kinase inhibitor, achieving high selectivity through structural innovation. It precisely targets the vascular secretory system, a central hub regulating vascular leakage, fibrosis, inflammation, and immune dysregulation, thereby intervening in the complex pathogenesis of IPF across multiple dimensions.
The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety window, potentially offering superior clinical benefits compared to existing standard therapies. Data from the Phase II clinical trial revealed that after 24 weeks of treatment, patients in the TDI01 400mg group demonstrated an 89mL improvement in Forced Vital Capacity (FVC) compared to the placebo group.
This improvement suggests a significant reduction in the risk of all-cause mortality for patients, while also effectively lowering the risks of IPF acute exacerbation and disease progression. Regarding safety, the incidence of serious adverse events and the rate of treatment discontinuation due to adverse events in the TDI01 treatment group were lower than those associated with comparable standard therapies, highlighting the favorable safety and tolerability profile of TDI01.
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