Kringle Pharma, Inc. announced that the clinical trial application has successfully submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to initiate a Phase III study of recombinant human HGF (KP-100LI) in patients with vocal fold scar. HGF, hepatocyte growth factor, is an endogenous protein responsible for regeneration and repair of tissues and organs in the human body. Its therapeutic effects have been validated in animal models of various diseases.

One of the multiple biological functions of HGF is its potent antifibrotic activity, and HGF is expected to be an effective therapeutic agent for various intractable fibrotic diseases. KRINGLE is focusing on vocal fold scar as a target indication of drug development for fibrotic diseases. The investigator-initiated Phase I/II study already completed, demonstrating the safety and efficacy of intracordal administration of HGF (Hirano et al.

J Tissue Eng Regen Med. 2018). The upcoming pivotal Phase III study is designed as a multicenter, randomized, placebo-controlled, double-blind, parallel-group study to confirm the safety and efficacy of KP-100LI in patients with vocal fold scar.

This study will be conducted at five clinical sites in Japan including University Hospital, Kyoto Prefectural University of Medicine. The Phase III study has been supported by the Japan Agency for Medical Research and Development (AMED) as its CiCLE program (Project title: Clinical development of recombinant HGF protein for the treatment of refractory fibrosis).