LungFit GO Safe, Well-tolerated, Interim Trial Analysis Shows
Treatment with LungFit GO, an inhaled form of nitric oxide that can be self-administered at home, has so far been well-tolerated in a pilot clinical trial testing the investigational medication in adults with or without cystic fibrosis (CF).
The ongoing trial involves patients with lung infections caused by non-tuberculous mycobacteria, known as NTM, which are environmental organisms found in soil, dust, and water. While these disease-causing bacteria usually aren’t transmitted person-to-person, such transmission has been reported in individuals with CF.
“Given these new interim safety and tolerability data … the future for the LungFit GO device is promising,” Andrew Colin, MD, a professor of cystic fibrosis and pediatric pulmonology director at the University of Miami, said in a press release.
The pilot study, now enrolling participants in Australia, is seeking to test the medicine in approximately 20 people with chronic, treatment-resistant NTM infections. People with CF or other diseases are more susceptible to lung infections caused by NTM — a set of more than 160 species of bacteria found naturally in the environment — with Mycobacterium abscessus posing a particular threat.
This bacteria, known as M. abscessus, has been associated with a greater lung function decline in this patient population.
“Refractory NTM lung infection is notoriously difficult to treat, and patients often suffer side effects and require complex dosing schedules to complete the 6-to-18-month combination antibiotic regimens that are the current standard of care,” Colin said.
LungFit GO is an inhaled version of nitric oxide (NO), a substance that has anti-inflammatory and bacteria-killing properties. NO also is a vasodilator — it prompts blood vessels to relax, thus lowering blood pressure.
This trial consists of a run-in period in which participants are evaluated before treatment, then given the medicine in two phases over the course of 12 weeks (about three months). In the first two-week treatment phase, the participants are being given increasing doses of NO, from 150 to 250 parts per million (PPM), in a hospital, while being monitored for safety. The participants then complete the rest of the study via at-home, self-administered treatment.
According to Colin, who specializes in lung disease, 250 PPM is “the highest concentration of inhaled NO that has ever been tested in a clinical trial with patient self-administration in the home.”
The new interim analysis includes data on eight participants enrolled in the study as of Sept. 6. All but one were female, and their ages ranged from 22 to 73, with a mean age of 56.6. This distribution is “consistent with real-world NTM disease,” according to Beyond Air, the company developing LungFit Go.
The doses given participants were increased up to the highest 250 ppm dose during the in-hospital phase. No patients required dose reductions during the subsequent at-home portion of the study. So far, there have been no study discontinuations, nor any serious side effects associated with treatment.
“We believe these data show that safe self-administration of nitric oxide at concentrations up to 250 ppm in the home setting is now a reality,” said Steve Lisi, chairman and CEO of Beyond Air.
“The Beyond Air team continues to work with our Australian colleagues, who have been outstanding in a difficult COVID-19 lockdown environment, to complete this study. We are encouraged by these interim data and look forward to reporting the complete efficacy and safety results, which are expected to be announced in 2022,” Lisi added.