Date: 2011-03-22
Type of information:
phase: 2
Announcement: phase 2a results
phase 2b initiation
Company: Biotest (Germany)
Product: BT-061
Action
mechanism: BT-061 is a humanized, therapeutic monoclonal antibody, which binds to and thus activates special cells of the immune system, the regulatory T cells.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On March 22, 2011, Biotest has announced that the clinical part of a phase II trial, in which the monoclonal antibody BT 061 was tested in combination with methotrexate for the treatment of Rheumatoid Arthritis, has now been concluded. In the double-blind, placebo-controlled, multicentre, multinational phase II trial, BT-061 was investigated for its efficacy and tolerability in the treatment of moderate to severe Rheumatoid Arthritis. The trial included patients who had already been treated with at least one DMARD (disease-modifying antirheumatic drug) but showed an inadequate response to this antirheumatic drug.Biotest previously published interim data from the first part of this trial, which showed good efficacy and good tolerability after intravenous administration of BT-061. In the second part of the trial, 30 patients were treated for eight weeks with weekly subcutaneous administration of 50 mg BT-061 in combination with methotrexate. Eleven patients in the placebo group were treated with methotrexate only. In a preliminary analysis, the response rate of the patients was assessed in week nine (after eight weeks of treatment) on the basis of the ACR score, an internationally accepted standard evaluation method of the American College of Rheumatology (ACR). After this eight-week treatment already, the symptoms improved by at least 50% (ACR 50) in 26% of the patients who completed the full treatment cycle according to the protocol. An improvement of the symptoms by more than 70% (ACR 70) was observed in 9% of the patients treated with BT-061. Improvements of 10% and 0% respectively (ACR 50/70) were obtained in the placebo group.The good tolerability of BT-061, which was expected based on the data from previous trials, has also been confirmed in the concluded phase II trial. The extent of symptom improvement as measured by the ACR score depends on the duration of treatment with all therapies. Maximum response rates, especially in the ACR 50 and ACR 70 scores, are usually achieved after four to six months of therapy. Comparatively high ACR 50 and ACR 70 scores were achieved with BT-061 after the relatively short treatment duration of only eight weeks. A further increase in efficacy is expected due to further optimisation of the dose, frequency of administration and particularly by extending the duration of treatment.Based on the interim analysis of this trial after intravenous administration of BT-061, a corresponding confirmatory phase IIb trial in Rheumatoid Arthritis was initiated with 176 patients. The duration of treatment will for the first time be 12 weeks. The first patients have already been included in this trial.
