Beyond Air Achieves Primary Endpoint in Pilot Bronchiolitis Study

High concentration nitric oxide (150 ppm) is statistically significant compared to both low concentration nitric oxide (85 ppm) and control arms on both the primary endpoint and the key secondary endpoint

No serious adverse events related to NO therapy

Third consecutive successful pilot study in bronchiolitis

GARDEN CITY, N.Y., May 20, 2020 (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 for the treatment of solid tumors, today announced positive top-line results from its third pilot study in bronchiolitis patients that showed, on an intent-to-treat (ITT) basis, 150 parts per million (ppm) NO is statistically significant compared to both the 85 ppm NO and control arms of the study.

The randomized, double blind, controlled study was performed at eight sites in Israel and enrolled 89 patients under the age of 12 months. 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.

For the primary endpoint, on an ITT basis, a comparison of relative hazards is displayed in the table below, which shows statistical significance of the 150 ppm NO arm compared to the other two arms.  For the key secondary endpoint of hospital length of stay (LOS), on an ITT basis, the results are also displayed in the table and 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 on either endpoint. 

	150 ppm vs. 85 ppm	150 ppm vs. SST	85 ppm vs. SST
Primary endpoint
Time to Fit-to-Discharge (FTD)
Hazard Ratio	2.11	2.32	0.90
95% CI	1.03, 4.31	1.01, 5.33	0.44, 1.81
P-value	0.041	0.049	NS
Secondary endpoint
Hospital Length of Stay (LOS)
Hazard Ratio	2.01	2.28	0.77
95% CI	1.01, 3.99	1.03, 5.06	0.40, 1.48
P-value	0.046	0.043	NS

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.