A further phase II trial of BT-061 in Rheumatoid Arthritis concluded
Preliminary analysis shows good clinical efficacy also in combination with the disease-modifying drug methotrexate
Effective dose range confirmed after subcutaneous administration of BT-061
First patients have been recruited in a phase IIb trial
Dreieich, GERMANY | March 22, 2011 | The clinical part of a phase II trial, in which the monoclonal antibody BT 061 was tested in combination with the disease-modifying drug 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, which has now been concluded, 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.
‘We are very pleased to announce the conclusion of the phase II trial’, commented Dr. Frank Osterroth, Head of Biotherapeutic segment at Biotest. ‘When therapeutic agents in Rheumatoid Arthritis are assessed, marked improvements in symptoms, as measured by the ACR 50 and ACR 70 scores, are particularly important. The fact that these two parameters show comparatively positive scores after only eight weeks of treatment again indicates the high potential of the immunomodulatory mechanism of BT-061. We anticipate that the efficacy will be further improved in the course of further clinical development by optimising the dose regimen and particularly by extending the duration of treatment.’
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.
About BT-061
BT-061 strengthens a natural function of the body that prevents excessive immune reactions. It is being developed to treat diseases due to an overreaction of the immune system.
About rheumatoid arthritis
Rheumatoid arthritis 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 industrialised 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 25 and 55 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.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for microbiology. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the Microbiological Monitoring segment are primarily used in hygiene monitoring. Biotest has more than 1,900 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 40
A further phase II trial of BT-061 in Rheumatoid Arthritis concluded
Preliminary analysis shows good clinical efficacy also in combination with the disease-modifying drug methotrexate
Effective dose range confirmed after subcutaneous administration of BT-061
First patients have been recruited in a phase IIb trial
Dreieich, GERMANY | March 22, 2011 | The clinical part of a phase II trial, in which the monoclonal antibody BT 061 was tested in combination with the disease-modifying drug 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, which has now been concluded, 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.
‘We are very pleased to announce the conclusion of the phase II trial’, commented Dr. Frank Osterroth, Head of Biotherapeutic segment at Biotest. ‘When therapeutic agents in Rheumatoid Arthritis are assessed, marked improvements in symptoms, as measured by the ACR 50 and ACR 70 scores, are particularly important. The fact that these two parameters show comparatively positive scores after only eight weeks of treatment again indicates the high potential of the immunomodulatory mechanism of BT-061. We anticipate that the efficacy will be further improved in the course of further clinical development by optimising the dose regimen and particularly by extending the duration of treatment.’
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.
About BT-061
BT-061 strengthens a natural function of the body that prevents excessive immune reactions. It is being developed to treat diseases due to an overreaction of the immune system.
About rheumatoid arthritis
Rheumatoid arthritis 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 industrialised 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 25 and 55 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.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic drugs as well as reagents and systems for microbiology. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the Microbiological Monitoring segment are primarily used in hygiene monitoring. Biotest has more than 1,900 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest AG
Post Views: 40
