FDA OKs Pivotal Trial Testing RheOx System in Chronic Bronchitis
The U.S. Food and Drug Administration (FDA) has cleared the start of an international pivotal trial to test the RheOx System, Gala Therapeutics’ medical device, in adults with chronic obstructive pulmonary disease (COPD) who have moderate to severe chronic bronchitis.
“Chronic bronchitis is a debilitating disease which results in symptoms that impact quality of life which commonly persist following guideline based medical treatment,” Frank Sciurba, MD, a co-principal investigator in the upcoming trial, said in a press release.
“Prior feasibility study results suggest that [the RheOx System] is well tolerated, reduces symptoms, and may significantly improve quality of life for patients,” said Sciurba, professor of medicine in the division of pulmonary and critical care medicine at the University of Pittsburgh. He also noted that the team looks “forward to studying this therapy in a larger, blinded, randomized trial.”
A subset of COPD, chronic bronchitis is characterized by airway chronic inflammation, daily cough, and excessive mucus production. Current treatments are mostly directed at widening the airways and decreasing inflammation, without addressing mucus overproduction.
The RheOx System was designed to reduce mucus-producing cells. It works by delivering a series of electrical pulses to kill the dysfunctional airway cells producing excessive mucus and to allow normal cells to grow in their place through a minimally invasive procedure called bronchial rheoplasty.
As such, the procedure, performed under general anesthesia and expected to last less than one hour, is thought to improve the cough and mucus symptoms of chronic bronchitis.
The system received the CE Mark in the European Union for the treatment of chronic bronchitis in 2019, meaning it met EU safety, health, and environmental protection requirements for marketing.
It was also granted breakthrough device designation by the FDA for the same indication — a designation meant to speed up its clinical development and regulatory review.
These decisions were supported by data from previous clinical studies, which showed the procedure was generally well tolerated and led to significant improvements in patients’ health-related quality of life and reductions in respiratory symptoms.
The upcoming trial, called RheSolve (NCT04677465), will evaluate the safety and effectiveness of the RheOx System in up to 270 adults, ages 35 and older, with COPD and moderate to severe chronic bronchitis.
Participants — expected to be recruited at up to 40 U.S. centers and 10 Canadian and European centers — will be randomly assigned to undergo either RheOx bronchial rheoplasty or a sham procedure (without electric pulses) in the right lung, and then in the left lung a month later.
The trial’s main goal is to assess changes up to six months post-treatment in the COPD Assessment Test (CAT) score, a questionnaire designed to measure the impact of COPD on a patient’s life.
“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,” Sciurba said.
Secondary goals include changes in other effectiveness measures, such as the rate of COPD exacerbations, cough frequency, and the number of excessive mucus-producing cells.
“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, MD, Gala’s CEO. “This is a significant milestone towards bringing a breakthrough therapy to millions of chronic bronchitis patients in the US.”
If positive, RheSolve’s results are expected to support a future application to the FDA requesting the approval of the RheOx System for the treatment of chronic bronchitis.
A post-market registry study in Europe (NCT04182841) is also collecting data on RheOx’s safety and effectiveness data in up to 100 COPD patients with moderate to severe chronic bronchitis.