- Biotest’s largest and most complex clinical study is running according to plan
- Patient recruitment completed. More than 300 patients enrolled within the past ten months
DREIEICH, Germany I September 9, 2014 I Biotest is pleased to announce that the last patient has been included into the Phase IIb study assessing the efficacy and safety of tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis. The Phase IIb study also known as TREAT 2b (T cell REgulating Arthritis Trial 2b) is the largest and most complex Biotest study to date. The trial is currently underway in 14 countries and more than 80 study centres in Eastern and Western Europe, the USA, Canada and Mexico. Treatment of patients in the TREAT 2b study continues as planned. Therefore the study is on track and Biotest expects, that the assessment of the endpoints of the study is achieved end of 1st quarter 2015 with top-line results to be reported in the 2nd quarter 2015.
TREAT 2b study is a double blind, randomised and placebo-controlled trial with four treatment groups, evaluating the efficacy and safety of tregalizumab
(BT-061) in patients with rheumatoid arthritis. In the active treatment groups and the main part of the study tregalizumab (BT-061) is administered at doses of 25, 100 and 200 mg subcutaneously once-weekly for a treatment duration of 24 weeks given in combination with methotrexate. Patients in the control arm receive methotrexate only. In patients who respond to treatment, the therapy can be extended for further six months in an ‘extension phase’. More information can be found on clinicaltrials.gov (identifier NCT 01999192).
“Biotest is committed to develop and market new medications in areas of high medical need. The unique mode of action of BT-061 will hopefully open a new therapeutic option for patients with rheumatoid arthritis and other autoimmune diseases with high efficacy and good quality of life. This new drug is developed in close cooperation with medical and scientific key opinion leaders worldwide,” said Prof Gregor Schulz, CEO of Biotest AG. Key data from the main part of TREAT 2b will be the basis for start of Phase III clinical development.
About Tregalizumab (BT-061)
Tregalizumab (BT-061) is a humanized monoclonal anti-CD4 antibody, which selectively activates regulatory T cells (Tregs). Tregalizumab (BT-061) thereby strengthens a natural function of the body that prevents excessive immune reactions. The antibody is being developed to treat diseases due to an overreaction of the immune system such as autoimmune diseases. Tregalizumab (BT-061) is currently in Phase IIb clinical development for rheumatoid arthritis.
About rheumatoid arthritis
Rheumatoid arthritis (RA) is a progressive inflammatory autoimmune disease that affects joints and organs. It is estimated that about 5 million people worldwide suffer from RA, with between 0.3 % and 1 % of the population of industrialized countries affected. The disease occurs three times more often in women than in men. Although RA can affect people of all age groups, the disease in most cases occurs between the ages of 40 and 60 years. Traditional treatment methods against rheumatoid arthritis include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic drugs (DMARDs). Treatments based on biotechnology preparations have been added recently.
SOURCE: Biotest
Post Views: 170
- Biotest’s largest and most complex clinical study is running according to plan
- Patient recruitment completed. More than 300 patients enrolled within the past ten months
DREIEICH, Germany I September 9, 2014 I Biotest is pleased to announce that the last patient has been included into the Phase IIb study assessing the efficacy and safety of tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis. The Phase IIb study also known as TREAT 2b (T cell REgulating Arthritis Trial 2b) is the largest and most complex Biotest study to date. The trial is currently underway in 14 countries and more than 80 study centres in Eastern and Western Europe, the USA, Canada and Mexico. Treatment of patients in the TREAT 2b study continues as planned. Therefore the study is on track and Biotest expects, that the assessment of the endpoints of the study is achieved end of 1st quarter 2015 with top-line results to be reported in the 2nd quarter 2015.
TREAT 2b study is a double blind, randomised and placebo-controlled trial with four treatment groups, evaluating the efficacy and safety of tregalizumab
(BT-061) in patients with rheumatoid arthritis. In the active treatment groups and the main part of the study tregalizumab (BT-061) is administered at doses of 25, 100 and 200 mg subcutaneously once-weekly for a treatment duration of 24 weeks given in combination with methotrexate. Patients in the control arm receive methotrexate only. In patients who respond to treatment, the therapy can be extended for further six months in an ‘extension phase’. More information can be found on clinicaltrials.gov (identifier NCT 01999192).
“Biotest is committed to develop and market new medications in areas of high medical need. The unique mode of action of BT-061 will hopefully open a new therapeutic option for patients with rheumatoid arthritis and other autoimmune diseases with high efficacy and good quality of life. This new drug is developed in close cooperation with medical and scientific key opinion leaders worldwide,” said Prof Gregor Schulz, CEO of Biotest AG. Key data from the main part of TREAT 2b will be the basis for start of Phase III clinical development.
About Tregalizumab (BT-061)
Tregalizumab (BT-061) is a humanized monoclonal anti-CD4 antibody, which selectively activates regulatory T cells (Tregs). Tregalizumab (BT-061) thereby strengthens a natural function of the body that prevents excessive immune reactions. The antibody is being developed to treat diseases due to an overreaction of the immune system such as autoimmune diseases. Tregalizumab (BT-061) is currently in Phase IIb clinical development for rheumatoid arthritis.
About rheumatoid arthritis
Rheumatoid arthritis (RA) is a progressive inflammatory autoimmune disease that affects joints and organs. It is estimated that about 5 million people worldwide suffer from RA, with between 0.3 % and 1 % of the population of industrialized countries affected. The disease occurs three times more often in women than in men. Although RA can affect people of all age groups, the disease in most cases occurs between the ages of 40 and 60 years. Traditional treatment methods against rheumatoid arthritis include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic drugs (DMARDs). Treatments based on biotechnology preparations have been added recently.
SOURCE: Biotest
Post Views: 170
