Beyond Air, Inc. announced that the Annals of the American Thoracic Society published a detailed review of the Company's third pilot study of inhaled NO in bronchiolitis patients. The publication offers an overview of the study design and previously announced results, as well as the rationale for conducting a pivotal study. The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).

This multicenter, double-blind, randomized-controlled study enrolled 89 patients under the age of 12 months who were hospitalized with moderate-severe bronchiolitis. The patients were randomized equally across three arms: standard supportive therapy (SST); 85 ppm NO + SST and 150 ppm NO + SST. Study treatment was delivered to patients intermittently four times per day for 40 minutes for up to five days.

The primary endpoint was time to fit-to-discharge (FTD), a composite of the modified TAL score and sustained oxygen saturation on room air. On an ITT basis, a significant reduction was observed in the primary endpoint when 150 ppm inhaled NO was compared to 85 ppm inhaled NO (HR = 2.11; 95% CI 1.03, 4.31; p = 0.041) and SST alone (HR = 2.32; 95% CI 1.01, 5.33; p = 0.0486). No significant difference was observed between 85 ppm NO and the control (HR = 0.90; 95% CI 0.44, 1.81; p = 0.76).

For the key secondary endpoint of hospital length of stay (LOS), on an ITT basis, the results show statistical significance of the 150 ppm NO arm compared to the other two arms. There was no statistical difference between the 85 ppm NO arm and SST. Also, NO therapy was generally well tolerated. There were no serious adverse events related to NO therapy, with no adverse events leading to discontinuation of NO therapy.

The study concluded that efficacy outcomes suggest intermittent administration of 150 ppm of inhaled NO may be favorable compared to the lower concentration, in shortening the time to improvement in clinically significant endpoints for hospitalized infants with moderate to severe bronchiolitis.