Beyond Air, Inc. announced positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, nontuberculous mycobacteria (NTM) lung disease. These data were presented in a rapid oral session at the American College of Chest Physicians (CHEST) Annual Meeting 2022, which is being held from October 16th to 19th in Nashville, TN. A total of 15 subjects were enrolled in the pilot study with a mean age of 62.1 years (range: 22-82 years), the majority of which were female (75%), a distribution consistent with real-world NTM disease.

Four separate strains of NTM were represented across subjects. All subjects were successfully titrated to 250 ppm NO in the hospital setting, and none required dose reductions during the subsequent at-home portion of the study. There were no occurrences of methemoglobinemia and no subjects discontinued NO therapy due to nitrogen dioxide (NO2) concentrations.

During the 10-week at-home treatment period of the study, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no serious adverse events (SAE) related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains.

Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed as shown in the chart below with statistical significance achieved at the 113/114 day timepoint. One subject achieved culture conversion with three consecutive negative sputum samples.

LungFit® GO NTM Trial Design: The 12-week, multi-center, open-label clinical trial was supported by a grant from the U.S. Cystic Fibrosis Foundation and took place in Australia for adult subjects with chronic refractory NTM lung disease. The trial enrolled both cystic fibrosis (CF) and non-CF subjects chronically infected with Mycobacterium avium complex (MAC), Mycobacterium abscessus complex (MABSC) or other strains of NTM who are refractory to standard therapies. The trial consisted of a run-in period followed by two treatment phases.

The run-in period provided a baseline for the efficacy endpoints, such as patient physical function and bacterial load. The first treatment phase took place over a two-week period and began in the hospital setting where subjects were titrated from 150 ppm NO up to 250 ppm NO over several days. During this first treatment phase subjects received NO for 40 minutes, four times per day while methemoglobin and nitrogen dioxide (NO2) levels were monitored (monitoring in-hospital only).

Subjects were trained to use the LungFit GO and were subsequently discharged to complete the remaining portion of the two-week treatment period at their home, continuing the established highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the inhalation treatments were administered twice daily at the same NO level. Subjects were evaluated for an additional 12 weeks after the end of treatment.

The study evaluated safety, tolerability, quality of life, physical function, and bacterial load among other parameters, as compared to baseline measurements.