This week, The Lancet Respiratory Medicine published encouraging safety and efficacy data from our Phase IIa study evaluating our novel investigational monoclonal antibody (mAb) benralizumab in patients with chronic obstructive pulmonary disease (COPD). This is the first clinical data to be published on a potential biologics treatment for COPD in patients with elevated white blood cells called eosinophils.
And, one has only to take a look at the global incidence and impact of COPD to understand why such data are so prospectively significant—millions of people suffer from the effects of COPD. For patients with the most ruthless symptoms, it changes their lives and limits them in ways that most of us can only imagine. This is why our goal has been to develop solutions for those with the most severe symptoms.
While not meeting its primary endpoint of reduction of exacerbations, what this important study in The Lancet demonstrated was that benralizumab improved lung function in an overall treatment group. And, in certain patient subsets, we saw reduced exacerbations—or attacks—and improvement in other COPD symptoms. The data support our commitment to a personalized health care approach to treating heterogeneous diseases like COPD.
We’ll be revealing more about this study in a poster presentation at the 2014 European Respiratory Society (ERS) International Congress in Munich, Germany being held this week, along with other data from our broad respiratory portfolio.
‘Clinically significant’ improvements
We’ve talked about benralizumab here in the past—for both asthma and COPD. This molecule is an anti-interleukin-5 (IL-5) receptor that depletes blood and sputum eosinophils. We know that elevated levels of eosinophils are connected to the cause and severity of COPD exacerbations, as well as asthma and asthma exacerbations.
Eosinophilic airway inflammation is associated with 20 to 30 percent of the approximately 210 million people worldwide who suffer from COPD.
Our study in The Lancet evaluated safety and efficacy in 101 adults with moderate-to-severe COPD, and at least one acute exacerbation requiring oral corticosteroids, antibiotics or hospitalization in the past year. While benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall patient population (as selected by elevated sputum eosinophils), we did see clinically significant improvements in a secondary lung function endpoint, determined by pre- and post-bronchodilator FEV1, or the amount of air a patient can forcefully blow out of her lungs in one second.
Also noteworthy is that we observed improvements in exacerbation rate, lung function and disease-specific health status as measured by the Saint George’s Respiratory Questionnaire-COPD (SGRQ-C). In pre-specified analyses, these were greater in benralizumab-treated patients with higher baseline levels of eosinophils in blood.
Promise for severe symptoms of COPD
To our knowledge, this makes benralizumab the first biological agent to show marked reduction in eosinophilic inflammation and beneficial clinical effects in COPD in Phase II studies.
These results form the basis for further development of benralizumab for COPD; more important, is that we have a potential new way to address an unmet need for patients with COPD, those who are not getting relief despite the use of current available treatments.
Also noteworthy is that we have strong support from clinicians, who understand the significance of this biologic and its potential impact for treating certain groups of patients with COPD. This includes growing evidence showing that reducing eosinophil activity and quantity seems to offer demonstrable benefits to patients with COPD and asthma.
So, we are continuing our efforts to better understand patient subtypes, identify potential biomarkers and to customize therapies that have the best chance of working for patients. And, we’re looking forward to pursuing the development of this promising new biologic as we progress our Phase III programs in both COPD and severe asthma.