– Phase IIa monotherapy trial completed
– Competitive clinical efficacy already after a short treatment period
– Good safety and tolerability profile confirmed
Dreieich, Germany | August 10, 2010 | Biotest AG is pleased to announce final data from a phase IIa clinical trial with its immunomodulatory antibody BT-061.
In the now completed multicenter, randomised placebo-controlled trial, 96 patients with active Rheumatoid Arthritis with an inadequate response to therapy with one or more traditional disease-modifying anti-rheumatic drugs (DMARD) were enrolled. Patients received BT-061 as a monotherapy at doses between 1.25 -100 mg as subcutaneous injection or 0.5-25 mg as intravenous infusion or placebo. Treatment was administered once weekly for 6 weeks. Patients included were randomly assigned to receive either BT-061 or placebo in a ratio of 3:1. In each dose group, six patients received active treatment and two patients received placebo.
Safety, tolerability and efficacy of BT-061 were evaluated. During the clinical trial, progressively higher dosages of the antibody were tested to identify the most active dose groups for subcutaneous and intravenous application of BT-061.
Clinical efficacy was evaluated on the basis of the ACR score, the internationally accepted standard rating system developed by the American College of Rheumatology.
Already after the short treatment cycle with BT-061 of only six weeks (evaluation week 7), in the most active subcutaneous dose group (50 mg), symptoms improved by at least 20% (ACR 20 response) in 67% of the patients, compared to 14% of the placebo group. An amelioration of parameters of at least 50% (ACR 50 response) was recorded for 33% of patients, and 17% of patients showed an improvement of symptoms of more than 70% (ACR 70 response). In the placebo group, the relevant values were 7% for ACR 50 and 0% for ACR 70.
The efficacious dose range for subcutaneous administration could be determined between 25 and 100 mg.
‘We are pleased to announce the completion of this phase IIa clinical trial and the promising efficacy data we obtained. In particular we are encouraged that despite the very short treatment cycle the obtained results look promising in comparison to the currently available gold standard for biologic therapy of Rheumatoid Arthritis. The completion of this trial is of particular importance to further support our ongoing discussions with potential strategic partners towards a global collaboration.’ stated Prof. Schulz, CEO Biotest AG.
In the concluded trial, no major safety signals have been identified and an overall good safety profile could be demonstrated. Detailed results from this study will be presented on international scientific congresses.
Currently, two clinical trials are ongoing in order to investigate the clinical efficacy and safety of BT- 061 in the lead indications Rheumatoid Arthritis and Chronic Plaque Psoriasis. Up to now 350 subjects have been enrolled in BT-061 studies. So far, BT-061 demonstrates promising efficacy and an overall good safety and tolerability in both lead indications. The data from this trial triggered the transition to a later stage of clinical development of BT-061. A new phase IIb trial (175 patients) with the goal to establish the statistical basis for pivotal testing has been initiated in August.
About BT-061
BT-061 enhances a natural mechanism of down regulating excessive immune responses and is therefore developed to treat disease conditions that originate from an overreaction of the immune system.
About Rheumatoid Arthritis
Rheumatoid Arthritis is a progressive autoimmune disease that causes chronic inflammation of the joints. It is estimated that five million people suffer from RA globally with 0.3 % to 1 % of the population in industrialized countries suffering from the disease. Women are three times more likely to be affected than men. Although it can affect people of all ages, the onset of RA usually occurs between the ages of 35-55.
Traditional treatments for RA include nonsteroidal anti-inflammatory drugs (NSAIDs),corticosteroids and disease-modifying antirheumatic drugs (DMARDs), with biological therapies a more recent addition.
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: 47
– Phase IIa monotherapy trial completed
– Competitive clinical efficacy already after a short treatment period
– Good safety and tolerability profile confirmed
Dreieich, Germany | August 10, 2010 | Biotest AG is pleased to announce final data from a phase IIa clinical trial with its immunomodulatory antibody BT-061.
In the now completed multicenter, randomised placebo-controlled trial, 96 patients with active Rheumatoid Arthritis with an inadequate response to therapy with one or more traditional disease-modifying anti-rheumatic drugs (DMARD) were enrolled. Patients received BT-061 as a monotherapy at doses between 1.25 -100 mg as subcutaneous injection or 0.5-25 mg as intravenous infusion or placebo. Treatment was administered once weekly for 6 weeks. Patients included were randomly assigned to receive either BT-061 or placebo in a ratio of 3:1. In each dose group, six patients received active treatment and two patients received placebo.
Safety, tolerability and efficacy of BT-061 were evaluated. During the clinical trial, progressively higher dosages of the antibody were tested to identify the most active dose groups for subcutaneous and intravenous application of BT-061.
Clinical efficacy was evaluated on the basis of the ACR score, the internationally accepted standard rating system developed by the American College of Rheumatology.
Already after the short treatment cycle with BT-061 of only six weeks (evaluation week 7), in the most active subcutaneous dose group (50 mg), symptoms improved by at least 20% (ACR 20 response) in 67% of the patients, compared to 14% of the placebo group. An amelioration of parameters of at least 50% (ACR 50 response) was recorded for 33% of patients, and 17% of patients showed an improvement of symptoms of more than 70% (ACR 70 response). In the placebo group, the relevant values were 7% for ACR 50 and 0% for ACR 70.
The efficacious dose range for subcutaneous administration could be determined between 25 and 100 mg.
‘We are pleased to announce the completion of this phase IIa clinical trial and the promising efficacy data we obtained. In particular we are encouraged that despite the very short treatment cycle the obtained results look promising in comparison to the currently available gold standard for biologic therapy of Rheumatoid Arthritis. The completion of this trial is of particular importance to further support our ongoing discussions with potential strategic partners towards a global collaboration.’ stated Prof. Schulz, CEO Biotest AG.
In the concluded trial, no major safety signals have been identified and an overall good safety profile could be demonstrated. Detailed results from this study will be presented on international scientific congresses.
Currently, two clinical trials are ongoing in order to investigate the clinical efficacy and safety of BT- 061 in the lead indications Rheumatoid Arthritis and Chronic Plaque Psoriasis. Up to now 350 subjects have been enrolled in BT-061 studies. So far, BT-061 demonstrates promising efficacy and an overall good safety and tolerability in both lead indications. The data from this trial triggered the transition to a later stage of clinical development of BT-061. A new phase IIb trial (175 patients) with the goal to establish the statistical basis for pivotal testing has been initiated in August.
About BT-061
BT-061 enhances a natural mechanism of down regulating excessive immune responses and is therefore developed to treat disease conditions that originate from an overreaction of the immune system.
About Rheumatoid Arthritis
Rheumatoid Arthritis is a progressive autoimmune disease that causes chronic inflammation of the joints. It is estimated that five million people suffer from RA globally with 0.3 % to 1 % of the population in industrialized countries suffering from the disease. Women are three times more likely to be affected than men. Although it can affect people of all ages, the onset of RA usually occurs between the ages of 35-55.
Traditional treatments for RA include nonsteroidal anti-inflammatory drugs (NSAIDs),corticosteroids and disease-modifying antirheumatic drugs (DMARDs), with biological therapies a more recent addition.
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: 47
