Boehringer Ingelheim registers Phase III AIRWARD trial of verducatib for COPD
- AIRWARD is a global Phase III randomized, double-blind, placebo-controlled trial of verducatib 2.5 mg versus placebo.
- The trial is expected to enroll ~1,800 adults from 450 sites in more than 25 countries, aged ≥40 with symptomatic COPD and eosinophils <300 cells/µL.
- Primary endpoint: annualized rate of moderate or severe exacerbations per person per year, assessed over at least 52 weeks and up to 76 weeks.
- Verducatib is an oral DPP1 inhibitor aimed at blocking activation of neutrophil serine proteases to address neutrophil-driven COPD; it is also in Phase III for bronchiectasis.
Trial registration and objective
The AIRWARD trial was registered on ClinicalTrials.gov (NCT07907991) to evaluate verducatib, an investigational oral DPP1 inhibitor, as a treatment for adults with symptomatic COPD who continue to experience exacerbations despite usual therapy and have blood eosinophil counts below 300 cells/µL.
Design and key measures
AIRWARD is a global, Phase III, randomized, double-blind, placebo-controlled study comparing verducatib 2.5 mg versus placebo. The primary endpoint is the annualized rate of moderate or severe exacerbations per person per year, measured over a period of at least 52 weeks and up to 76 weeks. Approximately 1,800 adults aged 40 years and older are expected to be enrolled across about 450 sites in more than 25 countries.
Mechanism and clinical rationale
Verducatib is designed to preferentially distribute to bone marrow and inhibit DPP1 to block activation of neutrophil serine proteases, targeting neutrophil-driven inflammation that the company estimates affects roughly 60–90% of people with COPD. The compound aims to reduce persistent inflammation, potentially lowering exacerbation frequency and influencing mucus production; its mechanism is supported by preclinical data and its clinical significance has not been established. Verducatib is also being studied in the Phase III AIRTIVITY trial for bronchiectasis.
Source: Boehringer Ingelheim