Kringle Pharma, Inc. announced that the first patient was enrolled in a placebo-controlled, double-blind Phase III study to evaluate the efficacy and safety of KP-100LI, the intracordal formulation containing recombinant human HGF, administered in patients with vocal fold scar. The first patient was screened and successfully enrolled for the study at University Hospital, Kyoto Prefectural University of Medicine. As announced in the company news release dated November 24, 2022, the study will be conducted at the five clinical trial sites across Japan including University Hospital, Kyoto Prefectural University of Medicine.

Patient enrollment will subsequently start at the other four clinical sites as soon as the contracts and all preparations are completed. 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).