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.

Press releases

Interim analysis supports continuation of clinical phas...

01.11.2016, News

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 ... [More]

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

06.10.2015, News

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 ... [More]

2009 brings additional growth

19.03.2010, News

2009 brings additional growth - Sales up by 14.1% to EUR440.2 million, EBIT improved by 4.2% - Important progress made in R&E projects - Expanded position as specialist for immunological and ... [More]

Biotest increases sales and earnings

05.11.2009, News

Biotest increases sales and earnings - Nine-month figures: sales increase by 12.0%, while EBIT grows by 3.0% - Forecast for the full year 2009 confirmed Dreieich, 5 November 2009. In the first ... [More]

Clinical development of BT-063 started

30.09.2009, News

Clinical development of BT-063 started - Monoclonal antibody for the lead indication systemic lupus erythematosus - Phase I clinical trial with 24 healthy volunteers started - All three ... [More]

Biotest achieves further milestones in its monoclonal a...

25.06.2007, News

Biotest achieves further milestones in its monoclonal antibody development · Phase I clinical trial confirms good tolerability profile of BT-061. · Start of production for the clinical testing ... [More]

Major milestones achieved in the development of monoclo...

21.12.2006, News

Major milestones achieved in the development of monoclonal antibodies. - Commencement of clinical development of BT-061. Approval by regulatory authority to begin clinical development with ... [More]

Clinical trials

Title

Indication

Status

 
BT-063 (Study 977) Healthy volunteers 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