Beyond Air Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19 with LungFit® PRO in a Poster Presentation at IDWeek 2022

Beyond Air, Inc. (NASDAQ: XAIR), a 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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive data from the LungFit^® PRO pilot study of high-concentration inhaled NO in Viral Community-Acquired Pneumonia (VCAP), including COVID-19.

Incremental data from the completed pilot study was provided in a poster presentation at IDWeek 2022, held from October 19^th to 23^rd in Washington, D.C., and the poster is available on the Events page of the Beyond Air website (click here). Initial topline data from the study were included in a presentation at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022) on April 25, 2022.

“The analysis of the LungFit PRO study in VCAP patients further demonstrates improved efficacy on multiple parameters in the iNO treatment group compared to standard supportive treatment (SST). This is the fourth study in hospitalized subjects suffering from viral respiratory infections completed by Beyond Air with NO concentrations of 150 ppm or more with all studies having data showing a strong safety profile and statistically significant results on key endpoints. We believe high concentration NO delivery with the LungFit PRO generator and delivery system can be a powerful tool against any type of pneumonia, especially COVID-19, and our company is dedicated to bringing this important therapy to market as soon as possible,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

The multi-center, open-label, randomized clinical trial in Israel enrolled a total of 40 subjects hospitalized for VCAP (COVID-19, n=39; other viruses, n=1). Subjects were randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO + SST) or standard supportive treatment alone (SST, control group). 35 subjects were included in the Intent To Treat (ITT) population, 16 in the inhaled NO + SST group and 19 in the control group. The primary COVID-19 treatments used during the study were Remdesivir (>30%) and Dexamethasone (>65%). Enrolled patients were followed for up to a 180-day period. The study endpoints include safety, and time on oxygen supplementation, among others.

Safety data from the study show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. There were two SAEs reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to study device or NO.

The efficacy results from the study are summarized below and show a trend of shortening LOS in favor of the inhaled NO treatment group. Also, duration of oxygen support, measured in-hospital and at home, was significantly shorter for inhaled NO treated subjects. Additionally, results from the study show a larger decline in c-reactive protein (CRP) from baseline for subjects treated with NO + SST compared to the control group.