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Beyond Air® Reports Positive Interim Results for LungFit® GO Pilot Study Using High Concentration Inhaled Nitric Oxide Self-Administered, At-Home for Nontuberculous Mycobacterial 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
About this update from Beyond Air, Inc.
[{"type":"text","content":"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® 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® 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 concent...