Bio-Thera Solutions announced that dosing has begun in Phase IA/IIB clinical trial to study efficacy and safety of BAT6026 in patients with moderate to severe atopic dermatitis. OX40 is an important autoimmune and inflammatory drug target, as OX40 is highly expressed by activated CD4+ and CD8+ T cells, which play an important role in many inflammatory diseases, such as atopic dermatitis (AD). BAT6026 not only blocks the OX40/OX40L interaction to prevent T cell activation and proliferation, but also specifically depletes activated OX40+ T cells through enhanced ADCC effect.

Therefore, BAT6026 is expected to treat many inflammatory diseases, including those mediated by Th2 cells. BAT6026 has an exciting preclinical profile and was shown to be safe and well tolerated in a Phase 1 dose escalation clinical study. The Phase IA/IIB, multicenter clinical trial of BAT6026 is designed to assess the efficacy and safety of BAT60 26 in patients with moderate to severe Atopic dermatitis.

Key objectives in the study include determining safety, tolerability, pharmacokinetics, and preliminary anti-inflammatory activity.