The FDA has approved an IND application from I-Mab Biopharma, a China-based clinical stage biopharmaceutical company for TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF), currently the best-in-class potential to treat autoimmune and inflammatory diseases. This Phase I initial first-in-human (FIH) single dose study will investigate safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of TJM2 in healthy volunteers (including Chinese subjects) in the United States.
GM-CSF is a critical pro-inflammatory cytokine that plays a pivotal role in tissue inflammation and destruction in autoimmune and inflammatory diseases such as rheumatoid arthritis and osteoarthritis.
Moderate to Severe Alopecia Areata (AA)
The sponsor's Phase IIa study met the primary efficacy endpoint in improving hair regrowth on the scalp relative to baseline at week 24 as measured by the Severity of Alopecia Tool (SALT) score (100 point scale). In addition to meeting the primary efficacy endpoint, subjects under investigation also met all secondary endpoints in the study. On the back of this positive Phase IIa data for PF-06651600, a pivotal Phase IIb/III trial will enroll an estimated 660 patients and will be a double-blind, placebo-controlled, dose-ranging study to evaluate the safety and effectiveness of PF-06651600 in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss.
AA is an autoimmune disease caused by the body's immune cells attacking healthy hair follicles, resulting in moderate to severe hair loss, often starting with smooth, round patches. The JAK pathways are believed to play an important role in such inflammatory processes and PF-06651600 is an oral JAK3 inhibitor that is also under investigation for the treatment of rheumatoid arthritis, Crohn?s disease and ulcerative colitis.