Autoimmune diseases, i.e. rheumatoid arthritis, systemic sclerosis
Mechanism of Action
FB704A is a fully human monoclonal antibody that inhibits IL-6/IL-6R signaling pathway by neutralizing IL-6. IL-6 pathway has emerged as a pivotal pathway involved in immune regulation in many cancers and immune disorders.
The biological function of FB704A has been verified in several vitro and in vivo studies, confirming the biological activities and anti-inflammatory efficacy are better than RA blockbuster drug, tocilizumab from Roche.
FB704A also completed GMP scale production and pre-clinical toxicology study, and obtained the US FDA IND permission for Phase I study in February 2018. The patient recruitment of Phase I study in the US has completed in May 2020. Data will be readout in September 2020.
About Systemic Inflammation Many innovative therapeutic approaches and clinical trials are targeting of the IL-6 pathway, specifically in treating rheumatoid arthritis (RA), autoimmune disease and cancers. FB704A has completed the phase I clinical study in the US with confirmed safety results in healthy subjects and RA patients. Additional indications of FB704A are under evaluated and reviewed, such as systemic sclerosis. Systemic sclerosis (SSc) is an autoimmune rheumatic disease characterized by changes in the texture and appearance of the skin. Visceral organs, including kidneys, heart and lung can also be affected by the fibrotic process and cause serious complications. Currently there is an unmet medical need in SSc treatment, though there is disease-modifying treatment for some of the symptoms. IL-6 implicates a vital role in the pathogenesis of SSc and associated with the fibrotic process of skin and lung. FB704A shows enormous potential in treating SSc.
Treating RA by blocking IL-6 pathway has been proved with clinical data. From market analysis, the market size of RA will reach 33.9 billion USD in 2025 (Reference: Fortune Business Insights).
In terms of SSc, the market size will reach 2.6 billion USD in 2026 globally (Reference: Grand View Research). As there is no biological competitor in the market, FB704A has tremendous potential in SSc.