– Final results of Phase I/IIa trial in chronic plaque psoriasis show long-lasting therapeutic effect after a single administration in the relevant dose levels
– Good safety confirmed by comprehensive testing
– First patients treated in a new phase II trial with repeated dosing
Dreieich, GERMANY | March 17, 2010 | Biotest reached another important milestone in the development of its monoclonal antibody BT 061. The analysis of the final unblinded data from a phase I/IIa clinical trial is now available. The antibody has been tested in an placebo-controlled, single dose, dose-escalation trial for the treatment of moderate to severe chronic plaque psoriasis. This clinical trial has focussed on pharmacokinetic properties of the antibody as well as its safety and efficacy.
In total, 55 patients have been treated of which 75% of the patients received BT-061 and 25% received placebo. The antibody was applied as single dose either intravenous (IV) or subcutaneous (SC) with dose levels ranging from 0.5 mg up to 25 mg (per dose level 7 or 8 patients).
Highest clinical efficacy, as measured by the PASI score,* was achieved with subcutaneous application. There was at least 50% improvement in the PASI (PASI 50) at day 75 in 60% of patients who received 25 mg BT-061 SC, as compared with 25% of those who received placebo. At the same time, in this dose group, 20% of patients receiving active drug had an improvement of at least 75% (PASI 75). In the corresponding placebo group, no PASI 75 was observed.
The clinical response lasted in single patients for up to 90 days. Detailed results of the trial will be presented at international scientific congresses.
‘We are encouraged to report the final data analysis which showed a very promising improvement of the PASI score,’ stated Dr. Frank Osterroth, Head of Biotherapeutic segment at Biotest. ‘Completion of this phase I/IIa trial is of particular importance to the further development of BT-061 in the indication Psoriasis.’
Comprehensive safety assessments were conducted by the Data Safety Monitoring Board (DSMB) and by Biotest in agreement with Paul-Ehrlich-Institute. Since no signs of risk became evident, dosage could be increased to the highest scheduled dosage level. In order to guarantee the highest level of safety for the patients, the trial was subject to very strict inclusion and exclusion criteria. As a consequence, a screening of 950 patients was necessary in order to enrol 55 patients in the trial. ‘These high safety requirements were the main reasons for the long duration of the trial,’ said Dr. Osterroth.
Based on the highly promising data achieved after single administration, a new phase II clinical trial has started in which BT-061 is given in repeated doses. This trial is a placebo controlled trial in which patients will be treated weekly for eight consecutive weeks in six different dose groups. This trial, too, is placebo-controlled. Its aim is to gain more insight into BT-061’s safety and efficacy profile in repeated doses. In addition, this study is designed to assess the most effective dose for the preferred subcutaneous application.
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.
Currently, three 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. Based on the data obtained so far, promising efficacy and an overall good safety and tolerability in both lead indications could be demonstrated.
Plaque psoriasis:
Chronic plaque psoriasis affects 1-3 % of the population in Europe and North America and is characterised by an excessive stimulation of growth of the keratinocytes, the most frequent cell type in the epidermis (the top layer of the skin). The clinical manifestation comprises large scaly and itchy patches and redness of the skin. It is associated with an increased prevalence of long-term complications such as psoriatic arthritis, cardiovascular diseases or diabetes.
*The PASI (Psoriasis Area and Severity Index) is a globally accepted measure for the assessment of extensive psoriasis. This measures the average redness, thickness and scaliness of the psoriatic lesions (each graded on a 0-4 scale), weighted by the area of involvement.
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: 604
– Final results of Phase I/IIa trial in chronic plaque psoriasis show long-lasting therapeutic effect after a single administration in the relevant dose levels
– Good safety confirmed by comprehensive testing
– First patients treated in a new phase II trial with repeated dosing
Dreieich, GERMANY | March 17, 2010 | Biotest reached another important milestone in the development of its monoclonal antibody BT 061. The analysis of the final unblinded data from a phase I/IIa clinical trial is now available. The antibody has been tested in an placebo-controlled, single dose, dose-escalation trial for the treatment of moderate to severe chronic plaque psoriasis. This clinical trial has focussed on pharmacokinetic properties of the antibody as well as its safety and efficacy.
In total, 55 patients have been treated of which 75% of the patients received BT-061 and 25% received placebo. The antibody was applied as single dose either intravenous (IV) or subcutaneous (SC) with dose levels ranging from 0.5 mg up to 25 mg (per dose level 7 or 8 patients).
Highest clinical efficacy, as measured by the PASI score,* was achieved with subcutaneous application. There was at least 50% improvement in the PASI (PASI 50) at day 75 in 60% of patients who received 25 mg BT-061 SC, as compared with 25% of those who received placebo. At the same time, in this dose group, 20% of patients receiving active drug had an improvement of at least 75% (PASI 75). In the corresponding placebo group, no PASI 75 was observed.
The clinical response lasted in single patients for up to 90 days. Detailed results of the trial will be presented at international scientific congresses.
‘We are encouraged to report the final data analysis which showed a very promising improvement of the PASI score,’ stated Dr. Frank Osterroth, Head of Biotherapeutic segment at Biotest. ‘Completion of this phase I/IIa trial is of particular importance to the further development of BT-061 in the indication Psoriasis.’
Comprehensive safety assessments were conducted by the Data Safety Monitoring Board (DSMB) and by Biotest in agreement with Paul-Ehrlich-Institute. Since no signs of risk became evident, dosage could be increased to the highest scheduled dosage level. In order to guarantee the highest level of safety for the patients, the trial was subject to very strict inclusion and exclusion criteria. As a consequence, a screening of 950 patients was necessary in order to enrol 55 patients in the trial. ‘These high safety requirements were the main reasons for the long duration of the trial,’ said Dr. Osterroth.
Based on the highly promising data achieved after single administration, a new phase II clinical trial has started in which BT-061 is given in repeated doses. This trial is a placebo controlled trial in which patients will be treated weekly for eight consecutive weeks in six different dose groups. This trial, too, is placebo-controlled. Its aim is to gain more insight into BT-061’s safety and efficacy profile in repeated doses. In addition, this study is designed to assess the most effective dose for the preferred subcutaneous application.
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.
Currently, three 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. Based on the data obtained so far, promising efficacy and an overall good safety and tolerability in both lead indications could be demonstrated.
Plaque psoriasis:
Chronic plaque psoriasis affects 1-3 % of the population in Europe and North America and is characterised by an excessive stimulation of growth of the keratinocytes, the most frequent cell type in the epidermis (the top layer of the skin). The clinical manifestation comprises large scaly and itchy patches and redness of the skin. It is associated with an increased prevalence of long-term complications such as psoriatic arthritis, cardiovascular diseases or diabetes.
*The PASI (Psoriasis Area and Severity Index) is a globally accepted measure for the assessment of extensive psoriasis. This measures the average redness, thickness and scaliness of the psoriatic lesions (each graded on a 0-4 scale), weighted by the area of involvement.
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: 604
