Verducatib

The Phase III AIRWARD™ trial was published today on ClinicalTrials.gov (NCT07907991).1AIRWARD will evaluate the efficacy and safety of verducatib, an investigational oral therapy for COPD.1The Phase III trial will enroll adults with symptomatic COPD who continue to experience exacerbations and have blood eosinophil counts below 300 cells/µL.1 Ingelheim, Germany and Ridgefield, Conn., U.S. - Boehringer Ingelheim today announced the registration of the Phase III AIRWARD™ trial evaluating its investigational oral therapy verducatib as a treatment option targeting DPP1 in adults with COPD; the trial was published on ClinicalTrials.gov (NCTXXXXXX).1 The trial will evaluate verducatib, an investigational dipeptidyl peptidase 1 (DPP1) inhibitor, in adults who continue to experience exacerbations, despite treatment with their usual therapy, and have a blood eosinophil count below 300 cells/µL.1 Building on more than 100 years of heritage in respiratory medicine and extensive experience in COPD, Boehringer is committed to addressing the needs of people who continue to experience exacerbations while receiving standard of care. “The AIRWARD trial marks a significant development in efforts to address one of the major challenges in lung health: disease driven predominantly by neutrophils, a reality affecting approximately 60 to 90% of people with COPD,” said Dr. MeiLan K. Han, Professor of Medicine and Chief of the Division of Pulmonary and Critical Care Medicine at the University of Michigan Health, and Principal Investigator for the AIRWARD trial. “There remains an unmet need for therapies that target underlying drivers of the disease. The AIRWARD trial gives us an important opportunity to explore an approach that could help change the future treatment of COPD.” In many people with COPD, chronic exposure to irritants triggers persistent and self-perpetuating neutrophil-driven inflammation in the lungs.2 AIRWARD will evaluate whether verducatib can reduce the frequency and severity of exacerbations in patients with COPD despite treatment with their usual therapy.1 “COPD is one of the world's most significant health challenges. Today, far too many patients remain underserved as frequent flare-ups drive reduced quality of life and lead to hospitalizations that place a significant burden on healthcare systems,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma. “With AIRWARD, we are broadening our verducatib program to explore its potential in COPD, reflecting our commitment to addressing the high unmet need in numerous lung diseases, and our broader pursuit of advancing lung health. But innovation alone is not enough: lungs can't wait. Policymakers, healthcare systems and industry need to work together to make lung health a higher priority through earlier diagnosis, better care pathways and faster access.” About COPD Chronic obstructive pulmonary disease (COPD) is a progressive, complex disease characterized by limited airflow, making it difficult to breathe.3 COPD is the third leading cause of death globally and is estimated to affect 213 million people worldwide.3,4 Common symptoms include shortness of breath and coughing, with or without excess mucus production.3 As a progressive and irreversible condition, COPD gradually diminishes lung function, with worsening symptoms that may significantly impact quality of life.3 Patients suffer from frequent and potentially severe lung flare ups, or exacerbations.3 In approximately 60 to 90% of people living with COPD, chronic inflammation is driven predominantly by neutrophils – white blood cells that respond to acute injury and infection.2,5 Neutrophils accumulate in the airways of the lungs in response to infection and inflammatory signals, releasing enzymes such as neutrophil serine proteases.2 When this activity becomes excessive, the resulting accumulation of tissue-damaging enzymes contributes to structural airway damage, emphysema and frequent flare-ups.6 As a result, many people continue to experience exacerbations that can accelerate disease progression, increase healthcare burden and negatively impact daily life.4 About AIRWARD™ The AIRWARD™ trial is a global, Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of verducatib 2.5 mg versus placebo in adults with COPD.1 The primary endpoint will measure the annualized rate of moderate or severe exacerbations experienced per person per year, comparing verducatib with placebo over a period of at least 52 weeks and up to 76 weeks. The trial is expected to enroll approximately 1,800 adults, from 450 sites and across more than 25 countries, aged 40 years and older with symptomatic COPD who continue to experience acute exacerbations despite treatment with their usual therapy, and with blood eosinophil counts <300 cells/µL.1 In addition to exacerbation rates, the trial will also evaluate secondary endpoints including time to first moderate or severe exacerbation, changes in lung function, and improvement in health-related quality of life.1 About verducatib (BI 1291583) Verducatib is an investigational drug that has not been approved for any proposed indication by any regulatory authority. Verducatib is an oral DPP1 inhibitor intended for preferential distribution to the bone marrow and the first DPP1 inhibitor to be studied in phase III for COPD. Verducatib has the potential to target a key pathway underlying chronic neutrophil-driven inflammation in COPD patients with normal-range blood eosinophil counts <300 cells/µL. By targeting the DPP1 enzyme to block the activation of neutrophil serine proteases, the aim is to help reduce persistent inflammation in COPD. Through this mechanism, the compound has the potential to reduce exacerbations and influence mucus production in the lungs of people living with COPD. In addition to COPD, verducatib is being investigated in the Phase III AIRTIVITY™ trial for bronchiectasis. The mechanism of action of verducatib is based on preclinical data and the clinical significance has not been established. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective. Our approximately 54,300 employees serve over 130 markets to build a healthier tomorrow. Learn more at www.boehringer-ingelheim.com. References 1 The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease ClinicalTrials.gov identifier: NCT07907991. Available at: https://clinicaltrials.gov/study/NCT07907991. Last Accessed October 2026. 2 Brightling CE, Greening NJ. Eur Respir J. 2019;54:1900651. 3 Global Strategy for the Diagnosis, Management, and Prevention of COPD. 2026 Report. Available at: goldcopd.org. Last Accessed October 2026 4 Cao Z, et al. BMJ Public Health. 2026;4:e002489. 5 Bhatt SP, et al. Int J Chron Obstruct Pulmon Dis. 2026. 6 Kreideweiss S, et al. Inflamm Res. 2023;72:1709-1717. Attachment Ingelheim, Germany