Phase III study of Cinqair did not meet endpoint in Severe Eosinophilic Asthma.

Teva Pharmaceutical announced that a Phase III registration study evaluating subcutaneously administered Cinqair (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 of more than 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.

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 at least 400/mcL showed significant reduction in CAE risk. This patient population is similar to those studied in the Phase III clinical trials for Cimqair (reslizumab) injection, the currently approved intravenous formulation, which also used a blood eosinophil count of at least 400/mcL. 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. Teva will review the full data to determine next steps.