Inmagene Biopharmaceuticals announced positive topline results from a Phase 2a trial of IMG-007, a non-depleting anti-OX40 monoclonal antibody, in patients with severe alopecia areata (AA). The 600mg dose cohort demonstrated a mean SALT (Severity of Alopecia Tool) score reduction of 21.7% at 36 weeks (eight months after the last dose), with continued improvement observed. The treatment was well-tolerated, with no serious adverse events reported.
These findings are particularly encouraging for AA patients, as current treatment options, primarily oral JAK inhibitors, necessitate daily dosing and carry potential safety risks requiring ongoing monitoring. IMG-007, administered intravenously over just four weeks, offers the potential for a less frequent, safer, and more effective long-term treatment option for this chronic autoimmune disease. The sustained reduction in SALT scores, even months after treatment cessation, suggests a durable therapeutic effect, addressing a significant unmet need in AA management.
The Phase 2a trial involved 29 patients across two dose cohorts (300mg and 600mg), with a baseline mean SALT score of 80.4. While the 300mg cohort showed minimal improvement, the 600mg group exhibited a 14.3% SALT reduction at 24 weeks and a 21.7% reduction at 36 weeks. Furthermore, patients in the 600mg group with baseline SALT scores between 50 and <95 experienced even greater improvement, achieving a 30.1% reduction at 36 weeks. Biomarker analysis revealed a significant inhibition of inflammatory markers associated with Th1, Th2, and CD8+ T cells at 16 weeks, further supporting the drug’s mechanism of action. These positive results pave the way for further clinical development of IMG-007 in AA. The data suggest that targeting the OX40-OX40L pathway may be a viable therapeutic strategy, potentially offering a much-needed alternative to existing treatments. The favorable safety profile and durable response observed in this study position IMG-007 as a promising candidate for a future, less burdensome treatment regimen for individuals suffering from AA.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
