On 30 September 2025, at the European Respiratory Society (ERS) Conference, held in Amsterdam, the Netherlands, Insmed presented results from a subgroup analysis from the Phase III ASPEN study (NCT04594369) that evaluated Brinsupri (brensocatib) in patients with non-cystic fibrosis bronchiectasis (NCFB). The analysis, which used Pseudomonas aeruginosa infection status as baseline, reiterated Brinsupri’s efficacy in reducing the annualised exacerbation rate versus placebo irrespective of P. aeruginosa status. The results will continue to strengthen Brinsupri’s clinical profile as it navigates the NCFB treatment landscape as the first-to-market therapy following its US Food and Drug Administration (FDA) approval in August 2025.
Results from the subgroup analysis were consistent with overall trial results that supported the FDA approval of Brinsupri. In the overall patient pool (N=1,721) that saw patients stratified by P. aeruginosa status, both 10mg doses (P. aeruginosa positive: N=203; P. aeruginosa negative: N=380) and 25mg doses (P. aeruginosa positive: N=205; P. aeruginosa negative: N=370) of brensocatib reduced the annualised exacerbation rate versus placebo, irrespective of infection status, which was the primary endpoint of the study (P. aeruginosa positive: 10mg dose: 1.04, 25mg dose: 1.22, placebo: 1.39; P. aeruginosa negative: 10mg dose: 0.99, 25mg dose: 0.94, placebo: 1.22). A similar outcome in favour of both doses of brensocatib was also observed in the annualised severe exacerbation rate (P. aeruginosa positive: 10mg dose: 0.21, 25mg dose: 0.21, placebo: 0.36; P. aeruginosa negative: 10mg dose: 0.11, 25mg dose: 0.11, placebo: 0.12).
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Patient-reported outcomes also improved with both treatment doses versus placebo. Within the subgroup analysis, this metric was measured by change from baseline in Quality-of-Life Bronchiectasis Respiratory Symptom Scale (QoL-B-RSS) at Week 52 (P. aeruginosa positive: 10mg dose: 8.10, 25mg dose: 10.28, placebo: 5.48; P. aeruginosa negative: 10mg dose: 6.13, 25mg dose: 7.51, placebo: 4.47).
In NCFB, the airways become inflamed with thick mucus that is difficult to clear, with build-up creating an environment for bacterial growth, leading to frequent infections. The positive results from the subgroup analysis will increase the confidence among physicians to use Brinsupri in NCFB patients who present with a similar clinical background as in the study.
Brinsupri is an oral inhibitor of dipeptidyl peptidase 1 (DPP-1) and targets neutrophilic serine proteases, which mediate neutrophilic inflammation. With its recent FDA approval, Brinsupri represents the first non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shifts away from use of off-label antibiotics in this disease space. As the first-to-market DPP-1 inhibitor in the respiratory field, Brinsupri is likely to become the standard of care in bronchiectasis treatment.
Key opinion leaders interviewed by GlobalData were excited by the agent’s ability to reduce exacerbations and slow the rate of lung function decline. According to GlobalData’s estimates, the bronchiectasis market is expected to be worth $3.7 billion in 2033 across the eight major markets (8MM: China, France, Germany, Italy, Japan, Spain, the UK and the US), growing at a compound annual growth rate of 9.8% from 2023–33, with the US and China together anticipated to account for 75% of the market by 2033. The recent findings from the ASPEN study will help Brinsupri to grow in the NCFB space, with the therapy projected to reach sales of $1.7 billion in 2033 across the 8MM, according to GlobalData estimates.
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