Development pipeline

BT-063

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.

Press releases

Phase IIa study demonstrates favorable safety and toler...

19.07.2018,

Phase IIa study demonstrates favorable safety and tolerability profile for Biotest's monoclonal antibody BT-063 for treatment of systemic lupus erythematosus (SLE)- Study meets primary endpoint for sa ... [More]

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 completed