Innovent Biologics announced the Phase I clinical study (CIBI112A101) of recombinant anti-interleukin 23p19 subunit antibody injection (IBI112) has completed the first healthy subject dosing in China.

The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety and tolerability (primary objective) in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects.

IBI112 is an interleukin-23 (IL-23) antibody, a cytokine with pro-inflammatory effect secreted by activated macrophages and dendritic cells. IL-23 promotes Th17 cell expansion, and the inflammatory response caused by various cytokines and chemokines such as IL-17 and IL-22 secreted by Th17 cells is associated with a variety of autoimmune diseases. IL-23 is composed of two subunits, p19 and p40, of which the p40 subunit is common to IL-23 and IL-12. IBI112 is a monoclonal antibody that selectively targets the p19 subunit of IL-23 but not the p40 subunit, so it can treat autoimmune diseases such as psoriasis by inhibiting the IL-23/Th17 pathway without affecting IL-12-mediated pathogenic defense and tumor immune surveillance.

"Currently, there are 2-3% of the world's population suffering from psoriasis, and about 6 million psoriasis patients in China. Regarding inflammatory bowel disease (IBD), the incidence trend is also rising significantly in the last few years. However, neither psoriasis nor IBD therapies have met the huge medical needs. Recently, IL-23 and other biological drugs have been attracting more and more attention due to the superior efficacy and safety profiles, but there are still no drugs targeting IL-23p19 independently developed in China yet,” Dr. Lei Qian, Senior Medical Director of Medical Science and Strategic Special Diseases Department of Innovent, said. “IBI112 is an innovative monoclonal antibody, independently developed by Innovent that can specifically bind to IL-23p19 subunit and block IL-23-mediated signaling pathway to achieve anti-inflammatory effect. It has potential to treat psoriasis, IBD and other autoimmune diseases. We saw good safety and efficacy data in the preclinical studies and believe this clinical progress of IBI112 is of great importance. We look forward to the results of subsequent clinical studies of IBI112 and hope to provide new treatment options for patients in need."

IBI112 is a monoclonal antibody independently developed by Innovent, with independent intellectual property rights. This product specifically binds to IL-23p19 subunit thereby preventing IL-23 from binding to cell surface receptors, blocking the IL-23 receptor-mediated signaling pathway. Preclinical data demonstrated a clear target, clear mechanism of action, and significant anti-inflammatory effect of IBI112, which indicate that IBI112 may provide a more effective treatment option for patients with autoimmune diseases.