Anti-OX40 Monoclonal Antibody IMG-007 Exhibited Clinical Activity of Hair Regrowth, Suppressed Scalp Inflammatory Biomarkers in Patients with Severe Alopecia Areata in a Phase 1b/2a Study

The study investigated the effects of IMG-007, an anti-OX40 monoclonal antibody, on patients with severe alopecia areata (AA). In this phase 1b/2a open-label study, 29 participants received either 300 mg or 600 mg doses of IMG-007. The 600 mg group showed significant improvement in hair regrowth, with a progressive reduction in SALT scores up to week 36, while the 300 mg group showed little change. IMG-007 was well-tolerated, with only mild or moderate adverse events. Biomarker analysis revealed normalization of inflammatory gene expression and partial restoration of hair-associated keratin genes. These findings suggest that IMG-007 could be an effective treatment for AA by blocking OX40-OX40L signaling.