Lebrikizumab is a humanized monoclonal antibody being developed by Genentech, a subsidiary of Hoffman La-Roche. It is a drug candidate aimed at treating inflammatory and fibrotic diseases. Owing to its immunosuppressive potential, it has been tested against diseases like asthma and refractory Hodgkin’s lymphoma with successful results. Researchers are now in the midst of a Phase 2 clinical trial in 484 adults with idiopathic pulmonary fibrosis (IPF). The trial’s estimated completion date is August 2017.
History of Lebrikizumab
Lebrikizumab was first developed by Texas-based biopharma Tanox under the name TNX-650. Genentech acquired Tanox in 2007 and initiated successful clinical trials, testing the drug in refractory Hodgkin’s lymphoma and asthma.
How Lebrikizumab Works
Lebrikizumab inhibits the secretion of Interleukin 13 (IL-13), a cell-signaling protein produced by Th2 cells in blood. IL-13 is responsible for the secretion of high amounts of periostin signaling protein, which is responsible for adhesion and migration of epithelial cells in the bronchi; bronchial hyper-responsiveness; activation and proliferation of fibroblasts; and several other factors involved in airway remodeling. As a result, IL-13 represents a formidable target for respiratory conditions.
Next Steps for Lebrikizumab in IPF
Based on the successful results in preclinical animal models and safety profiles in healthy human hosts, Roche moved forward with a Phase 2, randomized, double-blind, placebo-controlled, interventional study to assess the efficacy, safety, and tolerability of the drug in patients with idiopathic pulmonary fibrosis (IPF). The study started in October 2013 and is expected to be completed in August 2017. Clinical trial researchers are observing the effects of a fixed dose of the drug compared to a placebo in 484 IPF patients, both men and women, ages 40 and older.
Side effects of the drug observed so far include mild musculo-skeletal discomfort and upper respiratory tract infections in some patients, according to data from Phase 2 clinical trials with the drug in asthma patients.
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