Good Efficacy and safety data of previous trials confirmed
The study protocol of a new Phase IIb study (TREAT 2b) has been approved in several countries
DREIEICH, Germany I October 28, 2013 I Biotest AG today announced the presentation of efficacy and safety results from the Phase II study „979‟ at the Annual Meeting of the American College of Rheumatology (ACR) in San Diego, United States. The development of tregalizumab (BT-061), an antibody that selectively activates regulatory T cells, is an innovative and promising strategy for the treatment of rheumatoid arthritis. Biotest AG is undertaking the scientific and clinical evaluation of tregalizumab (BT-061) in collaboration with AbbVie.
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 12 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. At the end of the treatment period, change in disease was assessed using the following clinical parameters:
CDAI (Clinical Disease Activity Index), SDAI (Simple Disease Activity Index), ACR 20/50/70, and individual components of the ACR score, e.g. number of swollen and tender joints. At the beginning of the study, almost all patients had highly active disease. After 12 weeks of treatment with tregalizumab (BT-061), patients showed marked improvements of the CDAI score. In the best dose group, 37.5 % of patients had low disease activity and 3.1% were in remission. In the placebo group 3.1% and 0% of patients had low disease activity or remission, respectively.
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 good tolerability of tregalizumab (BT-061) observed in previous trials was also confirmed in this trial.
An additional analysis of pharmacodynamic data from all previous clinical trials further indicated that higher doses of tregalizumab SC once-weekly could provide higher efficacy. 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 6 months. In patients who respond to treatment, treatment can be extended for further 6 months in an ”extension phase“. The doses of tregalizumab (BT-061) being investigated are 25, 100 and 200 mg subcutaneously once-weekly. The target recruitment for this clinical trial is more than 300 patients. The study protocol has been approved by several regulatory agencies including Canada and some European countries. The treatment of the first patients will start within the next days.
SOURCE: Biotest
Post Views: 101
Good Efficacy and safety data of previous trials confirmed
The study protocol of a new Phase IIb study (TREAT 2b) has been approved in several countries
DREIEICH, Germany I October 28, 2013 I Biotest AG today announced the presentation of efficacy and safety results from the Phase II study „979‟ at the Annual Meeting of the American College of Rheumatology (ACR) in San Diego, United States. The development of tregalizumab (BT-061), an antibody that selectively activates regulatory T cells, is an innovative and promising strategy for the treatment of rheumatoid arthritis. Biotest AG is undertaking the scientific and clinical evaluation of tregalizumab (BT-061) in collaboration with AbbVie.
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 12 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. At the end of the treatment period, change in disease was assessed using the following clinical parameters:
CDAI (Clinical Disease Activity Index), SDAI (Simple Disease Activity Index), ACR 20/50/70, and individual components of the ACR score, e.g. number of swollen and tender joints. At the beginning of the study, almost all patients had highly active disease. After 12 weeks of treatment with tregalizumab (BT-061), patients showed marked improvements of the CDAI score. In the best dose group, 37.5 % of patients had low disease activity and 3.1% were in remission. In the placebo group 3.1% and 0% of patients had low disease activity or remission, respectively.
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 good tolerability of tregalizumab (BT-061) observed in previous trials was also confirmed in this trial.
An additional analysis of pharmacodynamic data from all previous clinical trials further indicated that higher doses of tregalizumab SC once-weekly could provide higher efficacy. 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 6 months. In patients who respond to treatment, treatment can be extended for further 6 months in an ”extension phase“. The doses of tregalizumab (BT-061) being investigated are 25, 100 and 200 mg subcutaneously once-weekly. The target recruitment for this clinical trial is more than 300 patients. The study protocol has been approved by several regulatory agencies including Canada and some European countries. The treatment of the first patients will start within the next days.
SOURCE: Biotest
Post Views: 101
