Beyond Air® Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit® PRO Programs at ATS 2021

Interim analysis from the ongoing, open-label, randomized acute viral pneumonia (including COVID-19) pilot study shows 150 ppm nitric oxide (NO) administered with LungFit® PRO is well-tolerated with no treatment-related adverse events, and demonstrates encouraging efficacy signals

Further analysis of 3 previously reported pilot studies in bronchiolitis at 150-160 ppm NO demonstrates a favorable safety profile and consistent efficacy across multiple endpoints

Entirety of data at 150-160 ppm NO in both adult and infant patient populations supports further development of LungFit® PRO in patients hospitalized with viral pneumonia

GARDEN CITY, N.Y., May 13, 2021 (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 (gNO) for the treatment of solid tumors, today announced the presentation of data at the American Thoracic Society (ATS) International Conference 2021, which is being held virtually from May 14 – May 19. The data from both LungFit® PRO programs, acute viral pneumonia (including COVID-19) and bronchiolitis, show a favorable safety profile and encouraging efficacy trends using high concentration inhaled NO for the treatment of acute viral lung infections in hospitalized patients.

“We have now demonstrated a consistently favorable safety profile at high concentrations of nitric oxide in both adult and infant populations with acute viral lung infections,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The new data from the acute viral pneumonia pilot trial in adults, taken together with our three previously completed pilot clinical trials in bronchiolitis, enable Beyond Air to prepare for a pivotal study for high concentration NO in a viral indication.”

“The interim analysis of patients in the acute viral pneumonia (including COVID-19) pilot study shows a favorable safety profile and encouraging efficacy signals in this adult patient population treated with 150 ppm NO generated and delivered by LungFit® PRO,” commented Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric Pulmonology, Miller School of Medicine, University of Miami. “Given these current data, I believe the results support the continued development of high concentration inhaled NO that can be delivered with ease by LungFit® for the treatment of viral pneumonia including COVID-19. LungFit® PRO is a revolutionary device that can allow for the treatment of this diverse patient population on a large scale”.

Summary of Interim Results of Acute Viral Pneumonia (including COVID-19) Pilot Trial

The ongoing acute viral pneumonia pilot study is a multi-center, open-label, randomized clinical trial in Israel with an emphasis on enrolling patients infected with SARS-CoV-2. Patients are 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). At the time of the cut off for these data, a total of 23 COVID-19 subjects were enrolled. The intent-to-treat (ITT) analysis population included 19 patients (9 NO + SST vs 10 SST).

Safety and Tolerability

• 150 ppm NO treatment administered via LungFit® PRO was safe and well tolerated.
• NO2 levels were below 4 ppm at all timepoints (safety threshold is 5 ppm).
• MetHb levels were below 4% at all times (safety threshold is 10%).
• A total of 15 adverse events were reported in 8 subjects (5 NO + SST vs. 3 SST) and two serious adverse events were reported in the NO + SST group – both were related to the underlying condition of the subject and were assessed to be unrelated to study treatment.
• There were no treatment-related, or possibly related, adverse events or severe adverse events.

Effect on Duration of Hospital Stay Intent to Treat Population

Intent to Treat Population with Exclusion of Extreme Values*

*2 subjects discharged from hospital within 6 hours of study enrollment were excluded from analysis.

Effect on Oxygen Support Requirements

• In the ITT population (n=19), 22.2% of subjects in the NO + SST group required oxygen support beyond their hospital stay, compared with 40% of control subjects.

Additional detailed study results will be submitted for presentation at an upcoming scientific meeting.

Summary of Analysis of 3 Completed Bronchiolitis Pilot Trials

“To date, over 90 patients hospitalized with a viral lung infection have received 150-160 ppm inhaled NO, dosed intermittently, without any reported treatment-related serious adverse events,” said Asher Tal, M.D. Professor Emeritus, Pediatrics, Soroka University Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. “Overall, the data show that 150 ppm NO given intermittently via inhalation is effective in the treatment of patients with bronchiolitis, while data at the lower concentration of 85 ppm show no benefits. I look forward to further development of the program using a minimum concentration of 150 ppm NO, noting that a reduction in time spent in the hospital by these patients would be clinically meaningful.”

Beyond Air has assessed inhaled NO in three pilot clinical trials in bronchiolitis. 198 infants (43% females; 57% males) participated across the three programs, with a mean age of 3.9 months (range 0.3 – 11.9 months). Inhaled NO treatments were given intermittently for 30 to 40 minute durations, from 4 to 5 times daily for up to 5 days. Data from patients in the SST group were pooled across the 3 studies for safety analysis.

Studies Included in the Analysis

Safety and Tolerability

• NO treatment administered intermittently was generally safe and well tolerated across the three pilot trials, with the adverse event rates similar among treatment groups.

Efficacy Conclusions

*Met statistical significance (p