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Beyond Air® Presents Positive Study Update from the At-Home LungFit® GO Pilot Study for Nontuberculous Mycobacterial Lung Disease at the American Thoracic Society International Conference 2022
A total of 2,323 inhalations have been self-administered at home to date with no treatment related discontinuations reported and overall high treatment
About this update from Beyond Air, Inc.
[{"type":"text","content":"A total of 2,323 inhalations have been self-administered at home to date with no treatment related discontinuations reported and overall high treatment compliance All subjects have successfully titrated to receive the target 250 ppm NO regimen at home 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., May 17, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive 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 (NTM) lung disease. These data were included in a poster presentation at the American Thoracic Society International Conference 2022 (ATS 2022), which is being held in San Francisco from May 13-18, 2022. The Company expects complete safety and efficacy results to be reported later in 2022. At the time of the data cutoff on April 4, 2022, a total of 15 subjects were enrolled in the pilot study. The mean age of subjects was 62.1 years (range: 22–82 years) with the majority female (80%), 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 t...