Aiming to uproot the market for asthma attacks, AstraZeneca and Avillion tout two PhIII wins for inhaled combo drug
A collaboration launched in 2018 between AstraZeneca and British company Avillion is bearing new fruit Thursday for a severe asthma program.
The AstraZeneca and Avillion candidate, dubbed PT027, met all primary endpoints in two Phase III studies, the companies announced Thursday. A combination of the short-acting beta2-agonist (SABA) albuterol — a common asthma medication — and the inhaled corticosteroid budesonide, PT027 is positioned to become the new standard of care for asthma rescue therapy, AstraZeneca senior VP for respiratory and immunology Mina Makar told Endpoints News.
“For 40 or 50 years plus, albuterol has been the standard of care to treat acute symptoms of asthma,” Makar said. “But for all of these years, part of the challenge has been that albuterol has not been treating the underlying inflammation of the asthma, where patients begin to over-rely on their albuterol inhalers and not get any relief of symptoms.”
Further data from more PT027 studies are expected in the first half of next year, but Makar said AstraZeneca and Avillion have everything they need right now to go to regulators. The companies expect to file for approval sometime in 2022.
Regardless of an individual’s asthma severity, the vast majority of patients carry around albuterol inhalers in case they experience an asthma attack. The medicine works by loosening the constriction of smooth muscle in the lungs, but does nothing to address the underlying inflammation of the condition, Makar said.
Where PT027 hopes to step in is by adding the inhaled corticosteroid to albuterol as part of the rescue therapy. It’s a treatment that has proven safe among other asthma maintenance supplements like Symbicort and Trelegy, he added. But the idea behind PT027 is that by combining the two in the rescue aspect, patients will be more likely to avoid hospitalization from severe attacks and the need for oral steroids.
“Those have significant toxicity and burden for patients in reducing exacerbations,” Frank Trudo, AstraZeneca VP of medical affairs for respiratory and immunology, told Endpoints.
Thursday’s announcement comes from two late-stage trials, enrolling roughly 4,100 patients across the asthma spectrum. The first study saw about 3,100 individuals with moderate to severe asthma taking maintenance therapy, while the second recruited about 1,000 patients with mild to moderate asthma who had previously received a SABA or maintenance as needed.
In the larger trial, PT027 statistically significantly reduced the risk of severe exacerbations compared to albuterol alone, when used as a rescue therapy in response to an asthma attack. AstraZeneca and Avillion did not release exact figures or a p-value, however, noting only that the primary was met at both the 180/160 μg and 180/80 μg doses.
The second study measured for a primary endpoint against both a comparator and placebo, with researchers looking at lung function. Again at both dose levels, PT027 showed a statistically significant improvement in lung function measured by the FEV1 test, or how much air an individual can breathe out in one second when forcibly exhaling.
This study also reported no exact figures or p-values. AstraZeneca and Avillion looked at the PT027 doses in comparison to albuterol alone, budesonide alone and placebo.
AstraZeneca originally got the ball rolling with Avillion back in March 2018, when the companies agreed to co-develop PT027 for asthma. Avillion took on all clinical development with AstraZeneca getting an option to commercialize and market the drug in the US upon a successful approval.
Now with the pivotal Phase III data in hand, Makar said the pair will need to initiate a “comprehensive” education program for patients and physicians, given how long albuterol has been used. But AstraZeneca is prepared to do that as it prepares the candidate for launch.
“Patients and physicians are very used to [albuterol] being the solution for acute symptoms,” Makar said. The programs will emphasize how there “needs to be inhaled steroid to deal with the underlying inflammation” in addition to albuterol.