Development pipeline

BT-063

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...

01.11.2016,

Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990)- Independent Data Safety Monitoring Board (DSMB) recommends to start part 2 of clinic ... [More]

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

06.10.2015,

Biotest 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 (SLE)- First pa ... [More]

Clinical trials

Title

Indication

Status

 
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