Date: 2014-10-09
Type of information: Publication of results in a medical journal
phase: 2b
Announcement: publication of results in the Lancet Respiratory Medicine
Company: AstraZeneca (UK)
Product: benralizumab
Action
mechanism: Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Rα) 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: severe asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On October 9, 2014, AstraZeneca announced that The Lancet Respiratory Medicine has published positive safety and efficacy data from a Phase IIb study evaluating benralizumab, a novel investigational monoclonal antibody, in patients with severe, uncontrolled asthma and elevated levels of eosinophils. The study met the primary endpoint, with patients taking benralizumab experiencing a statistically significant reduction in their asthma exacerbation rate versus subjects taking placebo over a period of one year. The study also met the secondary endpoints, with patients experiencing improvements in lung function and asthma control as measured by the Asthma Control Questionnaire (ACQ-6). The dose-ranging, placebo-controlled study was conducted by MedImmune, the company’s global biologics and research and development arm. The study evaluated adult patients with severe eosinophilic asthma that remained uncontrolled despite the use of medium or high dose inhaled corticosteroids and long-acting beta agonists for at least one year, and who had experienced at least two exacerbations in the past year. According to pre-specified analyses, benralizumab showed a greater reduction in asthma exacerbations in subgroups with higher baseline blood eosinophils. Specifically, the study showed that benralizumab reduced asthma exacerbations by approximately 40 to 70 percent depending on the dose received and baseline blood eosinophil level. The study also showed that benralizumab decreased blood eosinophil counts to low levels after the first dose. Overall, frequencies of adverse events, including treatment-emergent serious adverse events, were similar within the benralizumab and placebo groups. Common cold and skin reactions at the injection site occurred more frequently with benralizumab than with placebo. Benralizumab is currently in Phase III development for severe, uncontrolled asthma and COPD. A personalised healthcare strategy is included in the trial design where a simple blood test is used to identify patients with elevated blood eosinophils who are most likely to respond to therapy. The optimal dosing regimen is being evaluated in the Phase III studies.
