China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Hedgehog/SMO inhibitor, GT1708F, targeting idiopathic pulmonary fibrosis (IPF).
Understanding the Role of Hedgehog Signaling in IPF
Recent research has highlighted the critical role of the Hedgehog signaling pathway in the pathogenesis of IPF. GT1708F is a highly active and specific SMO protein inhibitor that modulates this pathway. By inhibiting SMO protein activity, GT1708F aims to alter the expression of downstream proteins associated with the Hedgehog pathway, thereby offering a novel therapeutic approach to treating IPF.
Previous Clinical Success and the Need for New Treatments
GT1708F previously completed a Phase I clinical trial in malignant hematological diseases in China, demonstrating good safety and tolerability, with no patients experiencing dose-limiting toxicity (DLT) or serious adverse events (SAE) related to the drug. Given the high incidence of IPF and the limited treatment options available—currently, only Boehringer Ingelheim’s Ofev (nintedanib) is approved for IPF in China—Kintor’s advancement of GT1708F could represent a significant development in addressing this life-threatening condition.-Fineline Info & Tech