Teva's subcutaneous reslizumab misses in Phase III for OCS-dependent asthma

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) reported top-line data from a Phase III trial in 177 patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils showing that 110 mg subcutaneous reslizumab every four weeks missed the primary endpoint of reducing daily OCS dose from baseline to week 24 vs. placebo. The company said it will evaluate the full data to determine next steps.

Secondary endpoints of the double-blind, international trial include proportions of patients with at least a 50% reduction in OCS dose, with a dose reduction to 5 mg daily or less, with a reduction of less than 5 mg and who discontinue treatment; percent change in OCS dose; annualized rate of clinical asthma exacerbations; time to first clinical asthma exacerbation; pre- and post-bronchodilator forced expiratory volume in one second (FEV1); peak expiratory flow (PEF); quality of life (QOL); nighttime awakenings due to asthma requiring a rescue inhaler; total asthma symptom scores; St. George’s Respiratory Questionnaire (SGRQ); total rescue inhaler use; pharmacokinetics; immunogenicity; and safety...