Date: 2014-07-31
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: AstraZeneca (UK)
Product: benralizumab
Action
mechanism: monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5R?) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Emerging evidence shows that for patients with elevated eosinophil counts, treatment with an IL-5 inhibitor in addition to guideline-based strategies may improve their asthma control and decrease the frequency of asthma attacks.
This antibody is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. Under the exclusive license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the US and Europe. BioWa is eligible for milestone payments and royalties related to the development and commercialisation of benralizumab in those countries.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Allergic diseases – Inflammatory diseases – Respiratory diseases
Country: Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark,Germany, Hungary, Israel, Italy, Mexico, The Netherlands, Poland, Peru, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland,Turkey, UK, USA
Trial
details: The GALATHEA study is a randomised, double-blind, 56 Week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and eafety of 2 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations. The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies. (NCT02138916) The TERRANOVA study is a randomised, double-blind, 56 Week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and eafety of 3 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations. The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies. (NCT02155660)
Latest
news: * On July 31, 2014, AstraZeneca announced that the first patient has been dosed in the benralizumab COPD Phase III Voyager programme. The programme includes two pivotal studies, Galathea and Terranova, studying benralizumab in patients with moderate to very severe COPD with high exacerbation risk despite receiving appropriate background therapies. The studies include patients with a range of blood eosinophil levels to allow identification of which patients may best respond to therapy. The primary endpoint of the studies is reduction in rate of exacerbation. Secondary endpoints include lung function (FEV1) and health-related quality of life.
