The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) announced its intention to collaborate with Insmed Incorporated to evaluate brensocatib 25 mg in a long-term, open-label, single-arm, interventional study. The study aims to enroll up to 3,000 patients with bronchiectasis across the United Kingdom, Spain, Germany, Belgium, France, and Italy over three years. The research is designed to deepen understanding of the long-term use of brensocatib and determine whether it has the potential to modify the course of the disease.
The intended study will expand upon current evidence that demonstrated brensocatib slows lung function decline, a measure used to indicate slower disease progression. It will evaluate whether earlier, upstream use of the therapy is effective in further slowing the progression of bronchiectasis. The plan includes well-validated endpoints along with some novel composite endpoints.
James Chalmers, MBChB, Ph.D., Rhodes Chair of Experimental Therapeutics and Respiratory Physician at the University of Oxford and lead study investigator, highlighted the study's ambition. "Building on ASPEN trial data showing that brensocatib 25 mg reduced exacerbation frequency, slowed lung function decline, and produced structural changes in the airways, this study through the EMBARC network will allow us to ask an even more ambitious question: whether intervening earlier in the disease course can do more than slow progression, but fundamentally alter its trajectory," said Chalmers.
Bronchiectasis is a serious, chronic, and progressive inflammatory lung disease characterized by the permanent widening of the airways. This leads to persistent bacterial infections, excessive mucus production, and recurrent pulmonary exacerbations, which are associated with accelerated lung function decline and poor quality of life. The condition affects approximately 600,000 people across Europe and millions globally.
Martina Flammer, M.D., MBA, Chief Medical Officer at Insmed, emphasized the significance of the collaboration. "EMBARC is one of the world's leading bronchiectasis research networks, and this collaboration reflects our commitment to understanding how brensocatib can make the greatest possible difference in patients' lives," said Flammer. "By studying brensocatib earlier in the disease course and over the longer term in a large, heterogeneous population, we hope to give patients the best possible chance of preserving their lung health."
Key Study Details
| Feature |
Details |
| Study Design |
Open-label, single-arm, interventional |
| Duration |
3 years |
| Target Enrollment |
Up to 3,000 patients |
| Dosage |
Brensocatib 25 mg |
| Locations |
United Kingdom, Spain, Germany, Belgium, France, Italy |
About EMBARC
The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative group within the Respiratory Infections Assembly of the European Respiratory Society (ERS). Its objective is to create a European bronchiectasis registry, harmonize existing databases, and identify opportunities to raise the profile of bronchiectasis at an international level. EMBARC brings together leading clinicians and researchers from across Europe to conduct high-quality interventional research and clinical trials.
About Insmed Incorporated
Insmed Incorporated is a global biopharmaceutical company advancing a diverse portfolio of approved and mid- to late-stage investigational medicines. The company's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. Insmed is headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan.
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