JERUSALEM, Israel I January 22, 2018 I Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint of significantly reducing the frequency of clinical asthma exacerbations (CAEs) in patients with uncontrolled asthma and elevated blood eosinophils >300/mcL. A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid (OCS)-dependent asthma did not meet its primary endpoint of reduction in daily OCS dose.
“We are disappointed that these trials of the reslizumab formulation administered subcutaneously at a fixed-dose of 110 mg did not meet their primary endpoints. However, these results reinforce the role of eosinophils in severe asthma disease biology and the importance of defining the right blood eosinophil cutoff point for patient selection. We continue to see the positive impact of the intravenous formulation as a clinically effective 3mg/kg weight-based dosing option in patients with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care therapy,” said Tushar Shah, MD, Senior Vice President, Specialty Clinical Development and Medical Affairs at Teva.
In the registration study, a pre-specified a priori-powered subgroup analysis of 80% of the total randomized severe asthma patient population with baseline blood eosinophil count of ≥ 400/mcL showed significant reduction in CAE risk (p <0.025). This patient population is similar to those studied in the Phase III clinical trials for CINQAIR®/CINQAERO® (reslizumab) injection, the currently approved intravenous formulation, which also used a blood eosinophil count of ≥ 400/mcL.
Teva will review the full data to determine next steps.
No new safety concerns to the known safety profile of reslizumab were identified in review of the data from these studies and no cases of anaphylaxis related to reslizumab were reported.
About the Studies
Study NCT02452190 was a registration Phase III, 52-week, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of reslizumab administered subcutaneously in 468 patients with uncontrolled asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs). For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02452190?term=NCT02452190&cntry1=NA%3AUS&rank=1
Study NCT02501629 was a claim-support Phase III, 24-week, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab administered subcutaneously in 177 patients with oral corticosteroid (OCS) dependent asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by reduction in daily OCS dose compared with baseline. For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02501629?term=reslizumab&cntry1=NA%3AUS&draw=2&rank=10
About CINQAIR®/CINQAERO® (reslizumab) injection for intravenous use
CINQAIR (reslizumab) Injection is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
SOURCE: Teva Pharmaceutical Industries
Post Views: 20
JERUSALEM, Israel I January 22, 2018 I Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint of significantly reducing the frequency of clinical asthma exacerbations (CAEs) in patients with uncontrolled asthma and elevated blood eosinophils >300/mcL. A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid (OCS)-dependent asthma did not meet its primary endpoint of reduction in daily OCS dose.
“We are disappointed that these trials of the reslizumab formulation administered subcutaneously at a fixed-dose of 110 mg did not meet their primary endpoints. However, these results reinforce the role of eosinophils in severe asthma disease biology and the importance of defining the right blood eosinophil cutoff point for patient selection. We continue to see the positive impact of the intravenous formulation as a clinically effective 3mg/kg weight-based dosing option in patients with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care therapy,” said Tushar Shah, MD, Senior Vice President, Specialty Clinical Development and Medical Affairs at Teva.
In the registration study, a pre-specified a priori-powered subgroup analysis of 80% of the total randomized severe asthma patient population with baseline blood eosinophil count of ≥ 400/mcL showed significant reduction in CAE risk (p <0.025). This patient population is similar to those studied in the Phase III clinical trials for CINQAIR®/CINQAERO® (reslizumab) injection, the currently approved intravenous formulation, which also used a blood eosinophil count of ≥ 400/mcL.
Teva will review the full data to determine next steps.
No new safety concerns to the known safety profile of reslizumab were identified in review of the data from these studies and no cases of anaphylaxis related to reslizumab were reported.
About the Studies
Study NCT02452190 was a registration Phase III, 52-week, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of reslizumab administered subcutaneously in 468 patients with uncontrolled asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs). For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02452190?term=NCT02452190&cntry1=NA%3AUS&rank=1
Study NCT02501629 was a claim-support Phase III, 24-week, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab administered subcutaneously in 177 patients with oral corticosteroid (OCS) dependent asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by reduction in daily OCS dose compared with baseline. For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02501629?term=reslizumab&cntry1=NA%3AUS&draw=2&rank=10
About CINQAIR®/CINQAERO® (reslizumab) injection for intravenous use
CINQAIR (reslizumab) Injection is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
SOURCE: Teva Pharmaceutical Industries
Post Views: 20
