Severe Asthma Drug Meets Primary Endpoint in Phase 3 Trial
Lebrikizumab caused a significant reduction of asthma exacerbations in people with high levels of serum periostin or blood eosinophils.
Two phase 3 clinical studies showed promising results for the safety and efficacy of lebrikizumab for people with severe asthma.
Together, both studies had 2100 participants enrolled across 28 countries with the primary endpoint measuring the rate of asthma exacerbations over 52 weeks.
The first study, LAVOLTA 1, met primary endpoints in showing a significant reduction of asthma exacerbations in people with high levels of serum periostin or blood eosinophils.
The results of the study also showed significant improvement in lung function, which was measured with forced expiratory volume in one second (FEV1). However, the LAVOLTA 2 study was not able to meet its primary endpoint because there was no statistical significance in exacerbation reduction.
Furthermore, the effects in the primary and secondary endpoints were less than those in the phase 2 trials.
"We were hopeful these identical studies would confirm the Phase II results because there is still a significant unmet need for people with severe asthma," said Sandra Horning, MD, chief medical officer and head of Global Product Development. "These data require further interpretation and analyses are ongoing to better understand the results and determine next steps."