Positive Results for Reslizumab in Asthma Trials
Teva announced positive results from its Phase 3 studies of reslizumab in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies. Reslizumab is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5).
Study NCT01270464 and Study NCT01508936 were 16-week, randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy and safety of reslizumab. Study NCT01270464 included patients 12–75 years of age (n=311) with eosinophilic asthma with a primary objective to determine whether reslizumab administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in these patients. Study NCT01508936 included patients 18–65 years of age (n= 492) with moderate to severe asthma with a primary objective to assess reslizumab's effect on FEV1 in relation to baseline blood eosinophils.
In Study NCT01270464, there were significant improvements in lung function vs. placebo when administered to patients, with moderate to severe asthma with elevated eosinophils. Improvement was measured by overall change in Forced Expiratory Volume in 1 second (FEV1) and were noted as early as four weeks after initial dose administration and were maintained at the end of the 16 week treatment period. Furthermore, reslizumab produced significant improvements in patient reported asthma control, assessed by using the Asthma Control Questionnaire (ACQ). Improvements in FEV1 and ACQ for the 0.3mg/kg dose were numerically smaller than for the 3mg/kgdose.
Results from Study NCT01508936, utilizing only the 3mg/kg dose of reslizumab, in an asthma population that was not selected for elevated blood eosinophils, demonstrated minimal improvements in asthma control, and provides support for the eosinophil threshold of ≥400/µL set for the reslizumab Phase 3 program.
Results from the two studies demonstrated that reslizumab treatment once every four weeks resulted in statistically significant reductions in the frequency of clinical asthma exarcebations compared to placebo (50% and 60% respectively, P<0.0001 for both).
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