GSK Submits IND Application in China for IL-18 Monoclonal Antibody GSK1070806

On September 12, the CDE website showed that GSK's IL-18 monoclonal antibody (GSK1070806) had applied for clinical trials in China.

GSK -1070806 is a humanized IgG1/kappa antibody targeting soluble cytokine IL-18.

Previously, GSK conductedAtopic dermatitis, Crohn's disease, delayed graft function (DGF) after kidney transplantation, and diabetesResearch, but DGF and late-stage diabetes were terminated due to insufficient efficacy and lack of efficacy, respectively. Crohn's disease also saw no progress after completing phase 1/2 trials in 2021. Currently, the only indication under research is atopic dermatitis, with phase 2 clinical results released in August this year.

Although IL-18 was discovered more than 30 years ago, breakthrough progress in fundamental research within related fields has only been achieved in recent years. Currently, there are no targeted IL-18 drugs on the market, and globally, there are only about a dozen pipelines under research. The most advanced is AB2 Bio, which has reached phase III with its product Tadekinig alfa (IL-18BP). It was previously granted orphan drug designation by the European EMA for the treatment of hemophagocytic lymphohistiocytosis (HLH). Subsequently, it also received FDA orphan drug, breakthrough therapy, and pediatric rare disease designations.