Suzhou, October 11, 2023 - Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that its Hedgehog/SMO inhibitor GT1708F had obtained conditional approval to conduct Phase II clinical trial in China by the National Medical Products Administration (NMPA) for treatment of idiopathic pulmonary fibrosis (IPF).

IPF is a chronic, progressive fibrosing interstitial pneumonia and one of the most fatal interstitial pneumonias. The incidence of IPF is high, but due to the relatively unnoticeable onset and progression, most patients are diagnosed in the moderate and advanced stages, and the median survival time of patients from the time of diagnosis is only 3~5 years^[1]. There are currently no effective therapies that can be used to stop the fibrosis process of IPF or cure the disease, and no new drugs for treating IPF have been approved in the past decade. There is a huge unmet clinical need. Currently, there are no Hedgehog/SMO inhibitors for IPF indication in the clinical stage in China, and the most advanced drug overseas for the same target is ENV-101 (Taladegib), which is conducting a Phase II clinical study for IPF indication. ENV-101 was in-licensed from Roche by Endeavor BioMedicines, which has received multiple rounds of financing for the development and advancement of the drug, showing the potential and market acknowledgment of Hedgehog/SMO inhibitors for treating IPF.

The latest research and clinical results show that the Hedgehog signaling pathway plays an important role in the pathogenesis of IPF. GT1708F is a highly active and specific inhibitor of SMO protein, which inhibits the activity of SMO protein to affect the activity of the Hedgehog pathway and the expression of its downstream related proteins, thereby treating IPF.

Previously, GT1708F completed the Phase I clinical trial in China for hematologic malignancies. The results showed that the GT1708F demonstrated good safety and tolerability, with no dose-limiting toxicity (DLT) and drug-related serious adverse events (SAEs) in patients.

Reference:

1. Raghu G, Collard HR, Egan JJ, et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med, 2011, 183(6): 788-824.