Boehringer Ingelheim has launched a phase 3 trial for verducatib, an investigational oral COPD therapy that targets the DPP1 enzyme to reduce neutrophil-driven inflammation in adults with ongoing COPD exacerbations. The AIRWARD study is enrolling patients aged 40 and older who have experienced at least two moderate or one severe COPD flareup in the past year.
- Drug Name & Target: Verducatib is an investigational oral therapy targeting the DPP1 enzyme to block neutrophil serine protease activation
- Trial Name & Phase: AIRWARD study (A Study to Test Whether Verducatib Helps People with COPD) is in phase 3 clinical testing
- Patient Eligibility: Adults aged 40+ with COPD who experienced at least 2 moderate or 1 severe exacerbation in the past year
- Study Duration: Participants commit to 1 year minimum through 1 year and 8 months, including regular site visits and monthly symptom monitoring
- Primary Endpoint: Annualized rate of moderate or severe COPD exacerbations measured through week 76
Registration is underway for a phase 3 trial to investigate verducatib, a COPD treatment for adults with blood eosinophil counts below 300 cells/mL.
The treatment’s manufacturer, Boehringer Ingelheim, said in a press release that the investigational therapy targets dipeptidyl peptidase 1 (DPP1) in adults who continue to experience COPD exacerbations.
The AIRWARD study, “A Study to Test Whether Verducatib Helps People with Chronic Obstructive Pulmonary Disease,” is open to adults aged 40 years and older who have COPD with ongoing symptoms. Participants must have had at least two moderate COPD flareups or at least one severe COPD flareup in the past year, including at least one while taking their current COPD treatment.
Participants will be in the study for one year minimum and up to a year and eight months, including regular visits to the study site and monthly phone calls to check on their COPD symptoms and health problems.
The primary endpoint of the study is the annualized rate of moderate or severe COPD exacerbations up to week 76.
The secondary endpoints include:
- Time to first moderate or severe acute exacerbation
- Time to first severe acute exacerbation
- A decrease of four points or more in the St. George’s Respiratory Questionnaire (SGRQ) total score by week 52
- Absolute change from baseline in post-bronchodilator FEV1 at week 52
- Absolute change from baseline in the SGRQ score at week 52
- Achievement of Evaluating Respiratory Symptoms COPD response rate by more than two points from baseline at week 52
- Achievement of a decrease of two points or more in the Chronic Airways Disease Assessment Test response by 52 weeks
Principal investigator MeiLan K. Han, PhD, said the AIRWARD trial is an effort to address one of the major challenges in lung heath: disease driven predominantly by neutrophils.
Researchers said verducatib has the potential to target a key pathway underlying chronic neutrophil-driven inflammation in COPD patients with normal-range blood eosinophil counts. By targeting the DPP1 enzyme to block the activation of neutrophil serine proteases, the aim is to help reduce persistent inflammation in COPD.
“There remains an unmet need for therapies that target the underlying drivers of the disease,” said Dr. Han, who is professor of medicine and chief of the division of pulmonary and critical care medicine at the University of Michigan Health. “The AIRWARD trial gives us an important opportunity to explore an approach that could help change the future treatment of COPD.”
Verducatib is an investigational drug that has not been approved for any proposed indication by any regulatory authority.
