Consider this: In the United States alone, the annual cost of asthma is about $56 billion and growing. This includes billions in direct costs, most of which goes to hospitalizations.
Besides the social and economic costs of a condition that affects nearly 300 million people worldwide, there’s an emotional impact for patients with the most severe cases of asthma and their families that is immeasurable—and, for most of us, unfathomable.
That’s where personalized healthcare can pick a fight.
Novel therapy being developed for severe asthma
This week, the first patient was dosed in the phase III investigational program for benralizumab—the first in a series of novel PHC-driven therapies targeting severe asthma.
More specifically, benralizumab binds to interleukin-5 receptor α, and through clever antibody engineering, is able to rapidly deplete eosinophils, white blood cells that are a key target in inflammatory respiratory disease and a hallmark feature in exacerbations of severe asthma.
The heterogeneous nature of asthma makes it especially difficult to develop across-the-board therapies that work for every patient, explains Bing Yao, PhD, MedImmune senior vice president, R&D, and Respiratory, Inflammation & Autoimmunity iMed head.
“The concept of one-size-fits-all medicine is unrealistic,” he says.
From failure-based to personalized therapy
Yao adds that the focus now is on developing targeted therapies with diagnostics to evolve treatment from a failure-based to a personalized approach for respiratory diseases like asthma. That’s a significant step toward a more broadly applied method to areas outside of hematology and oncology—where biomarkers and personalized medicine have had success.
But, the promise of benralizumab in a personalized healthcare approach is not merely conceptual. In part, it’s relied on identifying that key, easy to measure biomarker—blood eosinophils—in patients with severe, uncontrolled asthma.
“We know that eosinophils are a prominent feature of asthma and can be directly related to the severity of the attack, or exacerbation,” says Yao. “We’ve also shown through earlier trials that benralizumab reduces eosinophils and decreases exacerbations in patients with moderate to severe asthma with a safety profile that supports further clinical development.
Right drug, right target, right patient
These patients represent between 40 to 60 percent of all patients with eosinophilic asthma; patients who have already been treated with inhaled corticosteroids and other prescription medications, but whose symptoms remain uncontrolled.
Yao explains that benralizumab offers a novel mechanism of action targeted to deplete eosinophils for eosinophil-positive patients, who’ve been identified through a blood test.
Now, the goal of CALIMA, the first study in the phase III program, will be to determine whether the molecule reduces the number of exacerbations in patients with severe asthma who remain uncontrolled, despite high doses of inhaled corticosteroids in combination with a second controller like a long-acting beta agonist.
“It’s specific, targeted and refined,” says Yao. “It’s that right drug, right target, right patient trilogy that is the future of personalized healthcare.”
There are currently limited treatment options available for patients with severe uncontrolled asthma. We look forward to seeing the results of our phase III trial program for benralizumab as it has the potential to address an important area of unmet medical need.