AstraZeneca Moves Asthma Drug To Phase 3

AstraZeneca has advanced its asthma drug candidate tralokinumab to Phase 3 clinical trial for patients with severe, insufficiently controlled asthma.

Tralokinumab is an investigational human monoclonal antibody developed by AZ’s biologics R&D arm, MedImmune. The antibody selectively neutralizes interleukin-13 (IL-13), a cytokine considered to be a key contributor to the onset of severe and frequent asthma attacks. IL-13 is the suspected culprit behind impaired lung function and other debilitating asthma symptoms as it promotes inflammation, hyper-responsiveness of the airway, and excessive production of mucus in asthma patients.

The company will investigate the efficacy and safety of tralokinumab in decreasing the rate of asthma exacerbations (AER) in adult and adolescent patients who still have severe, deficiently controlled asthma following treatment with inhaled corticosteroids containing a long-acting β2-agonist. The Phase III trial will measure the effect of the drug on lung function and other symptoms. AstraZeneca said it will also try to investigate potential biomarkers that could indicate which patients are more likely to respond to the drug.

Bill Mezzanotte, VP and Head of Inflammation, Neuroscience and Respiratory in AZ’s Global Medicines Development unit, said that the company is excited to start the Phase 3 program for its drug. “Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease… Severe asthma is highly heterogeneous; we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies to cellular and molecular phenotypes to achieve the best clinical outcomes.”

The Phase 3 program was supported by positive results from a Phase 2B study completed by MedImmune. The biologics company presented the results at the 2014 American Thoracic Society (ATS) International Conference held in San Diego, California last May.

James Ward-Lilley, Head of the Respiratory, Inflammation and Autoimmune Therapy Area within Global Product and Portfolio Strategy at MedImmune, said, “Biologics offer real hope as a next generation of targeted asthma treatments designed to solve many problems for patients, and promise to be a strong growth driver in one of AstraZeneca’s core therapy areas.”