Positive Phase 2 Results for ARINA-1 in Treating NCFBE

Renovion, a biopharmaceutical firm, has announced encouraging results from its Phase 2 CLIMB study of ARINA-1, a novel nebulized therapy designed to alleviate mucus-related symptoms in patients with non-cystic fibrosis bronchiectasis (NCFBE), chronic bronchitis, and other respiratory conditions. The study, conducted across nine US sites, involved 40 participants with NCFBE, and demonstrated that ARINA-1 not only enhances the quality of life for patients but also has a lasting positive effect post-treatment.
The therapy's effectiveness was measured using the St. George’s Respiratory Questionnaire (SGRQ) and the Chronic Airways Assessment Test (CAAT), both of which showed significant improvements in patients' health status. Notably, the mean total score improvement in quality of life at day 28 of treatment was more than twice the minimal clinically important difference (MCID), and the placebo group did not meet the MCID for either assessment tool during the study.
ARINA-1 also showed a reduction in mucus viscosity and neutrophil elastase (NE) levels in sputum samples, aligning with its proposed mechanism of action and providing robust support for the observed improvements in quality of life. The treatment was found to be safe and well-tolerated, with no treatment-related serious adverse events reported during the 28-day trial period.
Charles Daley, MD, Principal Investigator of the CLIMB trial, highlighted the urgent need for new therapies for NCFBE, a condition that significantly impacts patients' quality of life and can lead to exacerbations. Renovion plans to progress ARINA-1 into a Phase 3 program for the treatment of NCFBE, with the potential to benefit millions of patients suffering from chronic mucus-related diseases.
The company will present the study outcomes at the American Thoracic Society Meeting and the World Bronchiectasis Conference. Renovion's ARINA-1 is part of a broader effort to develop therapies that restore lung health, with ongoing trials for lung transplant patients and an investigational study for those with chronic bronchitis. The Renovion team, with its extensive expertise in drug development and chronic pulmonary conditions, is committed to advancing treatments for respiratory diseases.