Teva Pharma announced positive new data from Phase III studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies. The data demonstrated that reslizumab treatment resulted in significant improvement in lung function and asthma control measures and showed a safety profile comparable to placebo.
Reslizumab treatment (3.0 mg/kg and 0.3 mg/kg IV injection every four weeks) resulted in significant improvements in lung function versus 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), a standard measure of the degree of airway obstruction in asthma. Improvements 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), which includes questions on symptoms, activity limitation, and the use of non-steroidal rescue medication. Improvements in FEV1 and ACQ for the 0.3 mg/kg dose were numerically smaller than for the 3 mg/kgdose.
The majority of reported adverse events (AEs) were mild to moderate and comparable across the treatment groups. The most common AEs in any treatment group were asthma, headache, nasopharyngitis, and upper respiratory tract infection.
“Uncontrolled asthma with eosinophilia is in desperate need of novel targeted therapies. The key aspects to the success of a treatment for these patients is the confidence and reduced impact on quality of life that comes from reduced exacerbations and the sense of normality that comes with better disease control. Reslizumab fulfills an important unmet need and has the potential to deliver on both counts,” said Dr. Leif Bjermer, principal investigator of the study and professor of respiratory medicine and allergology at Skane University Hospital in Lund, Sweden.
Results from a second study, utilizing only the 3 mg/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 III program.
“Teva has conducted an extensive and robust phase III clinical trial program that has clearly demonstrated the potential utility of reslizumab for patients who face a very challenging asthmatic condition. Reduced exacerbation, improved lung function and better asthma control positions reslizumab as a potential new targeted therapy for patients with uncontrolled asthma associated with elevated eosinophils,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd.”