An initial study evaluating the RheOx Bronchial Rheoplasty System for chronic bronchitis found clinically meaningful improvements in quality of life for patients after 12 months and demonstrated the safety and feasibility of the novel therapy, according to Gala Therapeutics Inc.
RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with chronic bronchitis. The technology includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for new normal cells to redevelop.
According to the 12-month data published in the American Journal of Respiratory and Critical Care Medicine, bronchial rheoplasty was performed successfully in 30 patients from five centers, with no device-related serious adverse events. Clinically meaningful improvements in quality of life were demonstrated through 12 months as measured using the COPD Assessment Test (CAT) and St. George’s Respiratory Questionnaire (SGRQ). Mean reductions from baseline in the CAT and SGRQ total scores were 7.0 and 15.2 points, respectively, exceeding the minimal clinically important differences of 2 points for CAT and 4 points for the SGRQ. These improvements were driven by a 28% reduction in cough and 41% reduction in mucus symptoms. Histopathological analysis of the airway mucosa showed a 39% reduction in mucus-producing goblet cell hyperplasia scores in the airways.
“There is a significant unmet need for a therapy that can improve the quality of life for chronic bronchitis patients,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “We are pleased with the results and are dedicated to continuing to build the clinical evidence for this therapy.”
“Chronic bronchitis is a debilitating disease that severely impacts a patient’s quality of life, and there is little we can do to treat these patients today,” said Arschang Valipour, MD, FCCP, Associate Professor, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Wien, Austria. “These study results demonstrate the technical feasibility of the procedure and a favorable safety profile. The improvements in symptoms and quality of life are compelling.”