The Phase III clinical trial of TDI01, a self-developed ROCK2 inhibitor by SINO BIOPHARM (01177), for the treatment of idiopathic pulmonary fibrosis has completed the enrollment of the first patient.

SINO BIOPHARM (01177) announced that the Phase III clinical trial of TDI01, a ROCK2 inhibitor developed by the company for the treatment of idiopathic pulmonary fibrosis (IPF), has completed the enrollment of the first patient. TDI01 is the world's first highly selective ROCK2 inhibitor to enter Phase III clinical trials for IPF. TDI01 is a ROCK2 kinase inhibitor with high selectivity achieved through structural innovation. It can precisely target the vascular secretory system, which regulates core mechanisms of vascular leakage, fibrosis, inflammation, and immune dysfunction, intervening in the complex pathogenesis of IPF from multiple dimensions. The high selectivity inhibition of ROCK2 by TDI01 can effectively optimize the drug's safety window, with the potential to achieve clinical benefits superior to existing standard treatments. Data from Phase II clinical trials show that after 24 weeks of treatment, patients in the TDI01 400mg group had a 89mL improvement in forced vital capacity (FVC) compared to the placebo group. This improvement significantly reduces the risk of all-cause mortality in patients, while effectively lowering the risk of acute exacerbations and disease progression in IPF. In terms of safety, the TDI01 treatment group had lower rates of severe adverse events and discontinuation due to adverse events compared to similar standard treatment drugs, demonstrating the good safety and tolerability of TDI01.