MENLO PARK, Calif.,—Gala Therapeutics has announced positive results from its first-in-human trial of RheOx in patients with chronic bronchitis. The data showed a favorable safety profile and clinically meaningful benefit after Bronchial Rheoplasty.
“There remains a clear unmet need for a therapy that directly targets cough and mucus hypersecretion in chronic bronchitis patients who are at increased risk of exacerbations, morbidity and mortality,” said Arschang Valipour, MD, FCCP, Associate Professor from the Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology at the Otto Wagner Spital in Vienna, Austria. Valipour presented preliminary results of the first-in-human study at the European Respiratory Society (ERS) in Paris, France on Monday September 17th in a late-breaking session.
The study is an ongoing multi-center study evaluating the safety and clinical effect of RheOx in patients with chronic bronchitis. Bronchial Rheoplasty is performed in two treatments, the first to treat the right lung airways and the second, one month later, to treat the left lung airways. A third bronchoscopy approximately three months after the second treatment is performed for sample collection only.
The primary endpoint of the study is safety. Secondary endpoints include changes in Quality of Life as measured by the Saint George’s Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT), as well as pulmonary function testing, histopathology and airway volume measures on CT scans. The results reported in this press release include data from thirty patients enrolled to date, including twenty-two patients who have reached the 3-month endpoint and are in varying stages of follow-up, with some beyond one year.
The primary endpoint of the study is safety. Secondary endpoints include changes in Quality of Life as measured by the Saint George’s Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT), as well as pulmonary function testing, histopathology and airway volume measures on CT scans. The results reported in this press release include data from thirty patients enrolled to date, including twenty-two patients who have reached the 3-month endpoint and are in varying stages of follow-up, with some beyond one year.
“These preliminary data demonstrate safety as well as significant improvement in Quality of Life, validated by biopsy evidence of a reduction in mucus-producing goblet cells and increases in airway volumes on CT scan imaging. This supports further study of RheOx as a potential new therapeutic option for a disease state that is not sufficiently addressed by pharmacotherapy,” Valipour mentioned.
Primary endpoint analysis revealed Bronchial Rheoplasty to be well tolerated in treated patients, with no device-related severe adverse events (SAEs). No unanticipated SAEs were reported. The secondary endpoint measures showed a reduction in mean SGRQ score of 16.1 points (p<0.05) at 3-months, which was sustained in the subjects that have reached 6 and 12 months. An improvement of 4 points is considered clinically meaningful, according to peer-reviewed literature.
Mucus and cough domains on the CAT score were reduced at 3 month follow-up by 38% and 45%, respectively, and were sustained at 6 and 12 months. Eighty-four percent of biopsy specimens were normal at the 3 month follow up, and there was a 23% increase in the distal airway volumes measured by CT scan, which in published literature has been predictive of a reduction in exacerbations.
Mucus and cough domains on the CAT score were reduced at 3 month follow-up by 38% and 45%, respectively, and were sustained at 6 and 12 months. Eighty-four percent of biopsy specimens were normal at the 3 month follow up, and there was a 23% increase in the distal airway volumes measured by CT scan, which in published literature has been predictive of a reduction in exacerbations.
“The data presented today strengthens our conviction that a targeted, device-based approach to treat the airways reduces mucus hypersecretion in subjects with chronic bronchitis. Patients were symptomatic at baseline despite being prescribed guideline-directed medications. These results may translate into therapeutic benefits in a wide range of pulmonary and non-pulmonary diseases that are similarly mediated,” noted Jonathan Waldstreicher, MD, Founder and CEO of Gala. “As a next step, we look forward to working with the physicians and sites in the United States that will treat the first patients in our Early Feasibility Study in the coming weeks.”
Earlier in July, Gala announced an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct an Early Feasibility Study (EFS) to examine the safety of the RheOx system in subjects with chronic bronchitis. The study will enroll up to 15 patients at 5 clinical trial sites in the United States.
“Patients with Chronic Bronchitis suffer daily with mucus hypersecretion and cough,” stated Waldstreicher. “We developed the Bronchial Rheoplasty procedure to directly treat the abnormal airway cells responsible for Chronic Bronchitis, which are not impacted by inhaled medications. We appreciate the FDA’s commitment to encouraging clinical development of medical devices in the United States through the EFS process.”
“In our early clinical work outside of the United States, we have demonstrated the safety and profound impact of Bronchial Rheoplasty in relieving chronic cough and mucus production, which has been confirmed with other objective measures of improvement,” commented Bill Krimsky, MD, Chief Medical Officer of Gala. “As a pulmonologist, I see these patients daily. We are now one step closer to offering them an outpatient minimally-invasive procedure to alter the usual downward spiral of this disease, which could become first-line therapy.”
