Benzinga | Oct 20, 2021 08:10AM EDT

Beyond Air Reports Interim Results From LungFit GO Pilot Study Using High Concentration Inhaled Nitric Oxide Self-Administered At-Home For Nontuberculous Mycobaterial Lung Disease

Interim results show that 250 parts per million (ppm) nitric oxide (NO) was well-tolerated with no study discontinuations or treatment-related serious adverse events observed

At the time of data cutoff, 8 subjects were successfully titrated up to 250 ppm NO with none having titrated down while in the study

LungFit(r) GO is the first NO generator and delivery system safely used in a clinical trial in the home setting with patients self-administering high concentration NO treatment

GARDEN CITY, N.Y., Oct. 20, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ:XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced positive interim data from the ongoing LungFit(r) GO pilot study in Australia. In this study, patients self-administered high concentration inhaled NO at home to treat severe nontuberculous mycobacterial (NTM) lung disease. The Company expects complete safety and efficacy results to be reported in 2022.

At the time of the data cutoff on September 6, 2021, a total of 8 subjects were enrolled in the pilot study. The mean age of subjects was 56.6 years (range: 22--73 years) with the majority female (87.5%), a distribution consistent with real-world NTM disease, and occurring at a higher rate in older adult women than men1. At baseline some subjects were diagnosed with more than one strain of NTM.

Interim data showed that high concentration inhaled NO was well tolerated with no study discontinuations and no treatment-related serious adverse events. All 8 subjects were successfully titrated to 250 ppm NO in the hospital setting, and none have required dose reductions during the subsequent at-home portion of the study. Methemoglobin and NO2 concentrations remained within acceptable ranges in all subjects during NO treatment, and below the safety thresholds of 10% and 5 ppm, respectively. The study continues to enroll patients, and the totality of the data will be used to evaluate efficacy measures including quality of life, physical function, and sputum bacteria as compared to baseline measurements.

"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. This therapeutic advance was made possible by the Beyond Air engineering team's ability and dedication to produce the LungFit(r) system. We believe that LungFit(r) GO will ultimately offer freedom to NTM patients, and others suffering from chronic refractory severe lung infections, by allowing them to self-administer treatment in the comfort of their own homes or anywhere they choose with a standard electric outlet available," said Steve Lisi, Chairman and Chief Executive Officer 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."

"I am very pleased with the safety profile of 250 ppm NO to date, as this is the highest concentration of inhaled NO that has ever been tested in a clinical trial with patient self-administration in the home. The bactericidal effects of high concentration NO on the Mycobacterium abscessus strain of NTM have been well documented in preclinical in vitro studies, along with its broad-spectrum activity against multiple bacterial and fungal pathogens at 200 ppm NO," commented Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric Pulmonology, Miller School of Medicine, University of Miami. "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. Given these new interim safety and tolerability data, with methemoglobin and nitrogen dioxide levels remaining at acceptable levels, the future for the LungFit(r) GO device is promising. I look forward to the final analyses of the full data set and hope to see results to support a move to a larger, definitive study in NTM patients. If successful, such a study could prove transformative for the lives of NTM patients."