James Chalmers, MBChB, PhD

Brensocatib, currently under US Food and Drug Administration (FDA) Priority Review, could become the first approved treatment for non-cystic fibrosis bronchiectasis and the first dipeptidyl peptidase 1 (DPP1) inhibitor, offering a novel approach to management of neutrophil-driven inflammation.

 on brensocatib from the ASPEN study were highlighted by James D. Chalmers, MBChB, PhD, professor of respiratory research at the University of Dundee, in a recent interview at the 

American Thoracic Society (ATS) International Conference

 in San Francisco, with consistent efficacy and safety being identified across all key patient subgroups. In this video segment, Chalmers highlighted several more unique takeaways from the subgroup analysis findings.

Unmet Needs for Non-Cystic Fibrosis Bronchiectasis, with James D. Chalmers, MBChB, PhD

“We have so many unmet needs in bronchiectasis, it's hard to know where to start,” Chalmers said. “This has been an incredibly neglected disease. It's been very little research over the last 20 to 30 years. It's great that we're starting to see an uptick in interest in this disease, recognizing it's a disease with a very high burden. It's really common, which means we really need to invest more into tackling some of these unmet needs. If you talk to a patient, what are the biggest concerns: frequent exacerbations, daily symptoms, and the concern that they're going to get worse over time. So it's really encouraging that brensocatib, if approved, looks like it would be able to address a lot of that.”

Chalmers highlighted additional unmet needs among patients with non-cystic fibrosis bronchiectasis. He noted the need for more treatments for people with bronchiectasis and the necessity of a concerted effort to diagnose the condition earlier and intervene in this condition earlier.

“Because unfortunately, that remains a big problem and many patients are undiagnosed,” Chalmers explained. “Many patients are misdiagnosed as having other conditions.”

Chalmers was also asked about what he hopes will be the biggest takeaways from the ASPEN trial findings on brensocatib, the subgroup analysis findings, and non-cystic fibrosis bronchiectasis in general.

“I'll start with brensocatib,” Chalmers said. “This is the first therapy that's been shown to be effective, and if approved, I hope that these data will reassure people that the efficacy is there. So there's a significant effect on exacerbations and on progression of disease, and it's consistent across all patient subpopulations, suggesting this can be a broadly applicable therapy. The second message, I would say, is inflammation. This is an anti-inflammatory therapy, and this validates the concept that targeting inflammation is a key way to treat people with bronchiectasis.”

In terms of what this would mean for clinicians and patients, Chalmers clarified that it would allow a reduced reliance on antibiotic implementation. He added that this is many patients’ biggest frustration, with constant consumption of antibiotics and their related side effects.

“The third thing I want to say as a key message is that we could have all the effective therapies in the world, but if we don't diagnose patients and get patients to the right care, they will never get access to those therapies and they won't have the effect they should,” Chalmers explained. “...Now that we have effective therapies, we should be prioritizing identifying these patients, diagnosing them earlier, and giving them access to the treatments that they need.”

To learn more about this data, view the full interview segment posted above. For more on late-breaking data and interviews at ATS, view our 

The quotes implemented in this summary were edited for clarity.

Correction: The adolescent data highlighted in the video was from a pre-specified analysis, not a post-hoc analysis.

Brensocatib Shows Consistent Efficacy and Safety Across Three Prespecified Subgroups in New Data from Landmark ASPEN Study. Insmed Incorporated. May 21, 2025. 

https://www.prnewswire.com/news-releases/brensocatib-shows-consistent-efficacy-and-safety-across-three-prespecified-subgroups-in-new-data-from-landmark-aspen-study-302462008.html?tc=eml_cleartime

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In this interview, Chalmers highlights the implications of his team’s subgroup analysis findings in the ASPEN trial, as well as unmet needs for non-cystic fibrosis bronchiectasis.

Chalmers discussed how brensocatib’s potential approval may transform the currently empty treatment landscape for bronchiectasis.

Investigating Brensocatib, Potential First Treatment for Bronchiectasis, with James Chalmers, MBChB, PhD

The FDA has accepted and granted priority review to Insmed’s New Drug Application (NDA) for brensocatib, a potential first treatment for patients with non-cystic fibrosis bronchiectasis. The therapy has a Prescription Drug User Fee Act (PDUFA) of August 12, 2025.

The NDA submission was based on data from the landmark Phase 3 ASPEN study, which met its primary endpoint of clinically and statistically significantly reducing the annualized rate of pulmonary exacerbations compared with placebo over 52 weeks in both its 10 and 25 mg dosages. The study assessed brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment, in adults and adolescents.

® spoke with James Chalmers, MBChB, PhD, Professor, Asthma and Lung UK Chair of Respiratory Research, MBChB, PhD, FRCPE, FERS, Clinical Professor (Teaching and Research) of Respiratory Research, Respiratory Medicine and Gastroenterology, University of Dundee, United Kingdom, who served as a primary investigator on the ASPEN study, to learn more about bronchiectasis and its unmet needs in the field. He discussed brensocatib and how it may benefit patients with bronchiectasis as the potential first treatment to be approved for the condition.

“[Bronchiectasis has] been neglected, a bit of a Cinderella condition. In 2011 the European Respiratory Society… described bronchiectasis as the most neglected disease in respiratory medicine, because there's so many patients, but nobody was really doing research into it, and nobody, nobody was doing any clinical trials. And so, it's really exciting that that's now changing, because our patients really need it to change. And this [potential] first licensed therapy is a step towards addressing that major burden,” Chalmers told 

Chalmers shared his excitement for the potential FDA approval of brensocatib and also discussed some priorities in bronchiectasis research and care that will follow after getting a first treatment.

FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025. News release. Insmed. February 6, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-insmeds-brensocatib-for-treatment-of-bronchiectasis-with-pdufa-target-action-date-set-for-august-12-2025-302369466.html

James Chalmers, MBChB, PhD

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