SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of Swiss drug maker Roche Holding AG (RHHBY), announced Monday top-line results from two Phase III studies, in which one study met its primary endpoint, while the second study did not meet the main goal.
The LAVOLTA I-II studies were identical, double-blind, randomized, multicenter, placebo-controlled studies that evaluated the efficacy and safety of lebrikizumab in people with severe asthma. The studies together included more than 2,100 people across 28 countries.
Lebrikizumab is a novel humanized monoclonal antibody designed to specifically block the action of interleukin-13 (IL-13), a cytokine that is a key contributor to airway inflammation and asthma disease processes in some people.
The primary endpoint of both studies was the rate of asthma exacerbations over 52 weeks.
LAVOLTA I met its primary endpoint, showing lebrikizumab significantly reduced exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation.
In contrast, the exacerbation reduction results observed in LAVOLTA II did not meet statistical significance. No new safety signals were observed in either study.
Results from the studies will be submitted for presentation at upcoming medical meetings.
The company noted that clinical studies in asthma, chronic obstructive pulmonary disease or COPD, atopic dermatitis and idiopathic pulmonary fibrosis are ongoing.
Copyright RTT News/dpa-AFX
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