Tregalizumab (BT-061) is a humanised monoclonal anti-CD4 antibody that selectively activates regulatory T cells (Tregs).
Tregalizumab thus reinforces a natural function of the body to prevent excessive immune reactions. The antibody with this new mechanism of action is being developed for the treatment of autoimmune diseases.
Clinical development of tregalizumab in rheumatoid arthritis was discontinued, after BT-061 did not met primary end-point in a Phase 2b trial. Pre-clinical work is currently ongoing to evaluate the MoA in other diseases.