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In its collaboration with Abbott, Biotest AG is pursuing an innovative therapeutic strategy to treat the autoimmune disorders Rheumatoid Arthritis and Chronic Plaque Psoriasis using the monoclonal antibody Tregalizumab (BT-061).
A phase IIa clinical trial with repeated doses has been completed in which Tregalizumab was tested for the treatment of chronic plaque psoriasis.
This trial was a placebo-controlled, double-blind, multicentre, multinational, multiple dose, dose-escalation study to evaluate the safety and efficacy of BT-061 in different doses and mode of administrations. Patients were treated subcutaneously or intravenously weekly for eight consecutive weeks in six different escalating dose groups. The primary endpoint of the study was PASI 75 (PASI : Psoriasis Area and Severity Index) response at Week 9, with PASI 50 and PASI 90 responses at Week 9 as secondary endpoints.
49 patients with Chronic Plaque Psoriasis were enrolled. Patients received Tregalizumab as monotherapy at doses between 25-100 mg as subcutaneous injections or 0.5 and 2 mg as intravenous infusions. Tregalizumab was administered once weekly for 8 weeks. In each treatment group, six patients received active treatment and two patients received placebo. After the treatment period, the patients were observed for further 12 weeks without Tregalizumab treatment (follow-up period).
Highest clinical response measured by the PASI score was achieved in the 100 mg dose-group. 71.4% of patients experienced at least a 50% improvement in psoriasis signs and symptoms as measured by PASI (PASI 50) at week 9, compared with 37.5% of those who received placebo. At the same time, in this dose-group, 42.9% of patients receiving active drug had an improvement of at least 75% (PASI 75) vs 12.5% for placebo.
In analogy to the results of the previous Phase I/II trial Study 967 (single dose administration), also in study 973 in the relevant active dose-groups, the PASI score generally further improved after the end of the 8 week treatment period. Further improvement of up to 90% (PASI 90) was observed in several patients during the treatment and follow-up period. The evaluation of response within the treatment and follow-up period (best response) showed a PASI 50 improvement in 71.4%, a PASI 75 in 57.1% and a PASI 90 in 14.3% of patients in the 100 mg SC dose-group. The respective numbers in the corresponding placebo group were 37.5%, 25.0%, and 0.0% (PASI 50, PASI 75, and PASI 90).
The good tolerability of Tregalizumab, which was expected based on the data from previous trials, has also been confirmed in the concluded phase IIa trial.
Further studies in Psoriasis in larger patient groups with a less frequent dosing schedule and a longer treatment period for Tregalizumab will only be started after finalisation of phase IIb trials in Rheumatoid Arthritis.
Source: pipelinereview.com
A phase IIa clinical trial with repeated doses has been completed in which Tregalizumab was tested for the treatment of chronic plaque psoriasis.
This trial was a placebo-controlled, double-blind, multicentre, multinational, multiple dose, dose-escalation study to evaluate the safety and efficacy of BT-061 in different doses and mode of administrations. Patients were treated subcutaneously or intravenously weekly for eight consecutive weeks in six different escalating dose groups. The primary endpoint of the study was PASI 75 (PASI : Psoriasis Area and Severity Index) response at Week 9, with PASI 50 and PASI 90 responses at Week 9 as secondary endpoints.
49 patients with Chronic Plaque Psoriasis were enrolled. Patients received Tregalizumab as monotherapy at doses between 25-100 mg as subcutaneous injections or 0.5 and 2 mg as intravenous infusions. Tregalizumab was administered once weekly for 8 weeks. In each treatment group, six patients received active treatment and two patients received placebo. After the treatment period, the patients were observed for further 12 weeks without Tregalizumab treatment (follow-up period).
Highest clinical response measured by the PASI score was achieved in the 100 mg dose-group. 71.4% of patients experienced at least a 50% improvement in psoriasis signs and symptoms as measured by PASI (PASI 50) at week 9, compared with 37.5% of those who received placebo. At the same time, in this dose-group, 42.9% of patients receiving active drug had an improvement of at least 75% (PASI 75) vs 12.5% for placebo.
In analogy to the results of the previous Phase I/II trial Study 967 (single dose administration), also in study 973 in the relevant active dose-groups, the PASI score generally further improved after the end of the 8 week treatment period. Further improvement of up to 90% (PASI 90) was observed in several patients during the treatment and follow-up period. The evaluation of response within the treatment and follow-up period (best response) showed a PASI 50 improvement in 71.4%, a PASI 75 in 57.1% and a PASI 90 in 14.3% of patients in the 100 mg SC dose-group. The respective numbers in the corresponding placebo group were 37.5%, 25.0%, and 0.0% (PASI 50, PASI 75, and PASI 90).
The good tolerability of Tregalizumab, which was expected based on the data from previous trials, has also been confirmed in the concluded phase IIa trial.
Further studies in Psoriasis in larger patient groups with a less frequent dosing schedule and a longer treatment period for Tregalizumab will only be started after finalisation of phase IIb trials in Rheumatoid Arthritis.
Source: pipelinereview.com