Favorable safety profile
- Favorable safety profile
- RheOx treatment resulted in clinical improvement as measured by Quality of Life scores, with treatment effect maintained at 12-month follow-up
- Improvement in airway biopsies and imaging
MENLO PARK, Calif., Sept. 17, 2018 /PRNewswire/ -- Gala Therapeutics (Gala), a clinical-stage developer of medical devices to treat pulmonary disease, today 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. “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 said.
Trial Design
The First-in-Human study is an ongoing, multi-center study evaluating the safety and clinical effect of RheOx in patients with chronic bronchitis. Bronchial Rheoplasty will be 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 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.
Results from First Cohort
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.
“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,” said 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.”
RheOx is an investigational medical device limited by United States law to investigational study only.
About Gala Therapeutics
Gala Therapeutics is a privately-held medical device company based in Menlo Park, CA that was formed by Apple Tree Partners, a life-sciences focused venture capital firm based in New York. Gala is dedicated to developing disease modifying therapies that improve survival, quality of life, and outcomes for patients with lung cancer, COPD, asthma, and other pulmonary diseases. Gala is building a portfolio of technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.
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SOURCE Gala Therapeutics
