China-based clinical stage biopharmaceutical company I-Mab Biopharma (I-Mab) declared on Sunday that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TJM2, which will be tested in clinical trials as a potential treatment option treat autoimmune and inflammatory disease such as rheumatoid arthritis and osteoarthritis.

TJM2 is a humanised immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) and is the first candidate from I-Mab's innovative proprietary pipeline to be approved for clinical trials by the FDA.

The company added that GM-CSF is a critical pro-inflammatory cytokine that plays a pivotal role in tissue inflammation and destruction in autoimmune and inflammatory diseases.

I-Mab stated that the initial first-in-human (FIH) single dose study will look at safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of TJM2 in healthy volunteers (including Chinese subjects) in the US.