Date: 2015-10-06
Type of information: Treatment of the first patient
phase: 2a
Announcement: treatment of the first patient
Company: Biotest (Germany)
Product: BT-063
Action
mechanism: monoclonal antibody. BT-063 is a humanised monoclonal antibody, which selectively neutralises human interleukin-10 (IL-10).
Disease: systemic lupus erythematosus (SLE)
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On October 6, 2015, Biotest announced that the phase IIa clinical study (Nr. 990) with the monoclonal antibody BT-063 in the lead indication systemic lupus erythematosus (SLE) has started with the first patient treated. BT-063 specifically neutralizes interleukin 10 (IL-10), which plays a crucial role in the development of the disease. With BT-063 Biotest pursues a completely new therapeutic approach to treat SLE patients. The safety of BT-063 has already been evaluated in a monocentric phase I study in healthy volunteers. In the currently initiated phase IIa study SLE patients in several European countries will be treated for three months with BT-063 (or placebo) in addition to their standard therapies. The primary goal of this clinical study is to investigate the safety and tolerability of the antibody in SLE patients. Furthermore, first data on efficacy of BT-063 in SLE patients are expected. Pharmacological investigations will be conducted in parallel to the clinical study 990 to obtain a more detailed understanding of BT-063\'s mode of action. Together with the study data these data will provide the basis for the planning of future clinical trials with BT-063 in its lead indication SLE.
