Date: 2014-03-05
Type of information:
phase: 2b
Announcement: presentation of results at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in San Diego, California, US
Company: Roche (Switzerland)
Product: lebrikizumab
Action mechanism: Lebrikizumab is a novel humanized monoclonal antibody designed to specifically block the action of interleukin-13 (IL-13), a cytokine that contributes to airway inflammation and asthma disease process in some patients. Blocking this cytokine may have beneficial effects in patients with IL-13-driven asthma and the biomarker periostin may predict benefit from anti-IL-13 therapy.
Disease: severe uncontrolled asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: LUTE and VERSE were replicate, multicenter, double-blind studies that randomized patients with severe uncontrolled asthma despite treatment with inhaled glucocorticosteroids (ICS) and a second controller to receive lebrikizumab 37.5 mg, 125 mg, 250 mg or placebo subcutaneously every four weeks. The LUTE / VERSE studies, initially phase III, were converted to phase IIb upon identification of a process-related impurity requiring changes to the lebrikizumab manufacturing process. The primary endpoint was the rate of exacerbations during the placebo-controlled period.
Latest
news: * On March 5, 2014, Roche has presented new data today from the LUTE / VERSE phase IIb studies investigating lebrikizumab in patients with severe uncontrolled asthma. The data showed that asthma attacks were reduced by 60 percent in lebrikizumab-treated patients with a high level of the biomarker periostin, compared to only 5 percent in patients with a low level of periostin. The data also showed that in patients with high periostin levels, lebrikizumab improved lung function as measured by FEV which reflects an increase in the maximum amount of air that can be forcibly exhaled in one second. Lebrikizumab was generally well-tolerated and the safety profile was consistent with previous study results. “We conclude based on these recent results that high levels of periostin, a protein that indicates a certain type of asthma, can predict which patients are most likely to benefit from lebrikizumab,” said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer at Roche. The new data released at AAAAI build upon previous positive phase II data, which were based on lebrikizumab treatment in patients who were uncontrolled despite inhaled corticosteroids. The LUTE / VERSE studies enrolled a more severe asthma population, as these patients were receiving high dose inhaled corticosteroids in addition to a second asthma controller therapy. Based on the results, lebrikizumab is currently being evaluated in adult patients with severe uncontrolled asthma in two phase III studies called LAVOLTA I and LAVOLTA II. Lebrikizumab is currently under investigation in seven ongoing or planned clinical studies, including one for idiopathic pulmonary fibrosis (IPF).
