Swiss drugmaker Roche has reported top-line results from its identical Phase III trials Lavolta I and Lavolta II, which evaluated lebrikizumab in people with severe asthma.
A total of 2,100 people across 28 countries were enrolled in the trials, which measured the rate of asthma exacerbations over 52 weeks.
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Lebrikizumab is a new humanised monoclonal antibody designed to specifically block the action of interleukin-13 (IL-13), a cytokine that sometimes contributes to airway inflammation and asthma disease processes.
The Lavolta I trial showed that lebrikizumab significantly reduced asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation.
Lavolta I also showed a significant improvement in lung function, as measured by forced expiratory volume in one second (FEV1).
The company noted that this effect was not observed in the lebrikizumab Phase II trials.
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By GlobalDataIt was reported that the second trial Lavolta II failed to meet the primary endpoint and there were no new safety signals observed in either study.
Roche Global Product Development head and chief medical officer Dr Sandra Horning said: "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.
"These data require further interpretation and analyses are ongoing to better understand the results and determine next steps."
Results from the trials will be submitted for presentation at forthcoming medical meetings.
The trials’ primary and secondary endpoints were observed in a subgroup of patients with higher levels of serum periostin or blood eosinophils.
Eosinophils are inflammatory cells that can be present in increased numbers in the airways and blood of people with asthma (eosinophilia), while periostin is a protein that has been identified as a key biomarker of inflammation in certain types of asthma.
