Development pipeline


BT-063 is a humanised monoclonal antibody, which selectively neutralises human interleukin-10 (IL-10).

IL-10 is involved in processes that lead to the differentiation and persistence of pathogenic B-cells in patients with SLE (Systemic Lupus Erythematosus). Neutralisation of IL-10 by BT-063 counteracts these processes and thus represents a possible new approach to the treatment of this autoimmune disease. A phase 1 clinical trial in healthy volunteers has been concluded. BT-063 is currently beeing examined in a phase IIa study in SLE patients.

Press releases

Interim analysis supports continuation of clinical phas...


/PRESS RELEASEInterim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990)- Independent Data Safety Monitoring Board (DSMB) recommends to start pa ... [More]

Biotest reaches the next milestone in the clinical deve...


/PRESS RELEASEBiotest reaches the next milestone in the clinical development of its monoclonal antibody BT-063 by starting the clinical phase IIa trial in the indication systemic lupus erythematosus ( ... [More]

Clinical trials




BT-063 (Study 977) Systemic lupus erythematosus Study completed

A prospective, open-label, mono-centre study to investigate safety, tolerability, pharmacokinetic and immunological properties of single IV doses of the humanised anti-IL-10 monoclonal antibody BT063

BT-063 (Study 990) Systemic lupus erythematosus Study ongoing