BT-063 is a humanized monoclonal antibody, which selectively neutralizes human Interleukin-10 (IL-10).
IL-10 is involved in processes, which lead to the differentiation and conservation of pathogen B-cells in patients who suffer from systemic lupus erythematosus (SLE).
The neutralization of IL-10 by BT-063 counteracts against those processes and represents a novel approach for treating this autoimmune disease. A Phase I clinical trial was successfully completed. Afterwards in a Phase IIa clinical trial BT-063 was tested in patients with SLE. The clinical trial/ reached its primary endpoint and demonstrated withal a generally positive safety profile for BT-063 in combination with the current standard of care.
For some patients first clinical improvements were seen through the early and continuous success of treatment, as was documented by the different indices for SLE.