Beyond Air announces new interim LungFit GO data

Beyond Air announced new interim data from the ongoing LungFit GO pilot at-home study in Australia. In this study, patients self-administered high concentration inhaled NO at home to treat severe nontuberculous mycobacterial, or NTM, lung disease. These data were included in a poster presentation at the American Thoracic Society International Conference 2022, or ATS 2022, which is being held in San Francisco from May 13-18. The company expects complete safety and efficacy results to be reported later in 2022. At the time of the data cutoff on April 4, a total of 15 subjects were enrolled in the pilot study. The mean age of subjects was 62.1 years with the majority female, a distribution consistent with real-world NTM disease. The data show that high concentration inhaled NO was well tolerated following a total of 2,323 inhalations self-administered at home with no treatment related discontinuations reported and overall high treatment compliance. All 15 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, below the safety thresholds of 10% and 5 ppm, respectively. Patients are followed up for 12 weeks after the 12-week treatment period is completed and the last patient visit at the end of week 24 will occur in August 2022. 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.