FDA Approves Pivotal Trial for Chronic Bronchitis Evaluation Tool

Gala Therapeutics Inc. (Gala) is preparing to start its RheSolve clinical trial, having received conditional Investigational Device Exemption approval from the U.S. Food and Drug Administration (FDA). 

“With the approval of this rigorously designed trial, we are ready to commence enrollment at major medical centers across the United States,” said Jonathan Waldstreicher, M.D., CEO of Gala Therapeutics. “This is a significant milestone towards bringing a breakthrough therapy to millions of chronic bronchitis patients in the U.S.”

The RheSolve trial is designed to evaluate Gala’s RheOx Bronchial Rheoplasty System for chronic bronchitis. Performed using a minimally invasive, bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System is designed to deliver non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, thereby improving the cough and mucus symptoms of chronic bronchitis. RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with chronic bronchitis.

The revolutionary 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. Patients treated with RheOx have reported improvements in symptoms and quality of life. RheOx is limited by federal (or United States) law to investigational use only. RheOx received CE certification in 2019 and has FDA Breakthrough Device Designation.

“Chronic bronchitis is a debilitating disease which results in symptoms that impact quality of life which commonly persist following guideline based medical treatment. Our collaboration with the COPD foundation to bring forward the CAT score as a meaningful patient reported measurement helped enable a study design centered on an outcome reflecting the patient’s experience,” said Frank Sciurba, M.D., professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the University of Pittsburgh, and co-principal investigator. “Prior feasibility study results suggest that Bronchial Rheoplasty using RheOx is well tolerated, reduces symptoms, and may significantly improve quality of life for patients. We look forward to studying this therapy in a larger, blinded, randomized trial.”
 
Building upon the positive results of previous studies, the RheSolve Trial is a double-blind, randomized, sham controlled study in COPD patients with moderate to severe chronic bronchitis. The study will randomize 270 subjects in a two-to-one ratio at up to 40 U.S. centers and up to 10 international centers. The trial will assess the safety and efficacy of the RheOx System when used to treat the symptoms of chronic bronchitis. The primary efficacy endpoint is the change from baseline to six months in the COPD Assessment Test (CAT) score.