Date: 2015-10-16
Type of information: Initiation of preclinical development
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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. SLE is an autoimmune disease which may affect various organs. Chronic inflammation may occur resulting in potentially severe organ damage. Approximately 5 million people worldwide suffer from this autoimmune disease. Within the last 50 years, only one new drug has been approved for the treatment of SLE. Therefore, the medical need for new therapeutic options is high. The monoclonal antibody 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. Dr. Andrea Wartenberg-Demand, Vice President Corporate Clinical Research at Biotest pointed out: \"This is a major milestone in the clinical development of BT-063. In this clinical study with the humanized anti-IL-10 antibody, we hope to confirm the results regarding indications of efficacy and tolerability that were obtained during a previous study. Llorente et al., Arthritis & Rheumatism (2000) We hope these results will bring us one step further in the development of a new therapeutic option to treat patients suffering from this serious disease.\"
