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Biotest AG Announces Positive Results of Phase II Study '979'.

Monday, 28 Oct 2013 11:30am EDT 

Biotest AG announced that it confirms efficacy and safety results from the Phase II study '979'. The development of tregalizumab (BT-061), an antibody that selectively activates regulatory T cells, is a strategy for the treatment of rheumatoid arthritis. Study 979 was a randomized, multi-centre, placebo-controlled study to investigate the safety and efficacy of tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate. Patients were treated with tregalizumab (BT-061) for twelve weeks in three different dose groups (25, 50, 75 mg), each by subcutaneous administration once-weekly in combination with methotrexate. The control group received methotrexate and placebo. ACR 20 responses (improvement of disease activity by at least 20%) were observed in up to 56% of patients treated with tregalizumab, and up to 37% and 7% of patients had improvements of disease activity of 50% (ACR 50) or 70% (ACR 70) respectively. The tolerability of tregalizumab (BT-061) observed in previous trials was also confirmed in this trial. Based on these data and an interim analysis of Study 979, Biotest previously announced in spring 2013 the initiation of a new Phase IIb study, called 'TREAT 2b' (T cell REgulating Arthritis Trial 2b). In this study tregalizumab (BT-061) is given in combination with methotrexate subcutaneously for six months.