Teva's subcutaneous reslizumab misses in Phase III for eosinophilic asthma

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) reported top-line data from a Phase III trial in 468 patients with uncontrolled asthma and elevated blood eosinophils of of >300 eosinophils per µL showing that 110 mg subcutaneous reslizumab every four weeks missed the primary endpoint of reducing the frequency of clinical asthma exacerbations at week 52 vs. placebo. The company said it will evaluate the full data to determine next steps.

Teva said a subgroup analysis of patients with at least 400 eosinophils per µL showed that reslizumab significantly reduced clinical asthma exacerbation risk vs. placebo (p<0.025). The company said that the subgroup is similar to patients in Phase III trials of the IV formulation of reslizumab, which is approved to treat eosinophilic asthma as Cinqair in the U.S. and as Cinqaero in the EU...