AstraZeneca already has its aging two-drug inhaler Symbicort as a maintenance treatment for asthma. Now, with a pair of trial wins, the company looks on track to have a novel doublet for controlling an attack in progress.
Two large trials have hit their goals showing that PT027, a fixed-dose combo of short-acting beta2-agonist (SABA) albuterol and inhaled corticosteroid (ICS) budesonide, could help asthma patients better than its individual components alone when used as a “rescue” therapy in response to symptom exacerbation, AstraZeneca unveiled Thursday.
PT027 could be a valuable addition to AZ’s growing respiratory arsenal. In a July note, Jefferies predicted the combo med could reach $500 million in peak sales.
An estimated 71 million rescue inhalers are used in the U.S. each year, with the market worth about $2.6 billion, according to Jefferies. The current U.S. asthma treatment guidelines recommend using ICS and SABA together after treating intermittent asthma with a SABA, the team noted.
A fixed-dose inhaler with both components could offer patients more convenience, the analysts said.
AZ and partner Avillion tested PT027 against different efficacy measures in two trials. In the Mandala trial, PT027 showed “statistically significant and clinically meaningful” reductions in the risk of severe exacerbations versus albuterol. The trial included over 3,000 patients with moderate to severe asthma who were taking maintenance ICS.
The 1,001-participant Denali trial, meanwhile, tested PT027 for its ability to improve lung function. Compared with solo albuterol, budesonide or placebo, asthma patients who were previously treated with a SABA alone or in combo with maintenance ICS therapy enjoyed significantly better improvement in the volume of air exhaled in one second when treated with the investigational combo.
As PT027 demonstrated it can dampen inflammation and prevent exacerbations as a rescue inhaler, the doublet combo could be an important potential new option for asthma patients, Bradley Chipps, M.D., former president of the American College of Allergy, Asthma & Immunology, said in a statement.
If approved, PT027 would be the first ICS/SABA combo rescue inhaler for asthma in the U.S. The drug uses the company’s Aerosphere delivery technology. Other meds using the same platform includes newly approved three-in-one COPD therapy Breztri and COPD doublet Bevespi.
Most of the growth in AZ’s respiratory department is driven by Fasenra, a biologic drug for the add-on maintenance treatment of severe asthma with a high count of the white blood cells eosinophils. The drug’s sales in the first half of 2021 reached $580 million, an impressive 36% year-over-year growth rate.
Meanwhile, AZ and partner Amgen are awaiting the FDA's decision for another biologic asthma drug tezepelumab that could reach patients with low levels of eosinophils. The drug has mixed results in two phase 3 trials, showing it could reduce asthma attacks but couldn’t cut back the use of oral corticosteroids.