Beyond Air, Inc. (XAIR) Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit® PRO Programs at ATS
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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
|LungFit 150 ppm NO + SST||SST|
|Duration of hospital stay (days)||N||9||10|
Intent to Treat Population with Exclusion of Extreme Values*
|LungFit 150 ppm NO + SST||SST*|
|Duration of hospital stay (days)||N||9||8|
*2 subjects discharged from hospital within 6 hours of study enrollment were excluded from analysis.
Effect on Oxygen Support Requirements
|LungFit 150 ppm NO + SST||SST|
|Duration of Oxygen Support (days)||N||9||10|
- 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
|Trial 1||Trial 2||Trial 3|
|Treatment groups||160 ppm NO + SSTSST alone (control)||160 ppm NO + SSTSST alone (control)||150 ppm NO + SST85 ppm NO + SSTSST alone (control)|
|Total Intent to Treat (ITT) Subjects Enrolled & Evaluated as the Safety Population||43||68||87|
|Study Treatment Protocol||Inhaled NO was given for 30 minutes, 5 times per day for up to 5 days||Inhaled NO was given for 30 minutes, 5 times per day for up to 5 days||Inhaled NO was given for 40 minutes, 4 times per day for up to 5 days|
|Primary objective||Safety||Efficacy(Length of Stay)||Efficacy(Time to Fit for Discharge)|
Safety and Tolerability
|SST (N=82)||85 ppm NO + SST (N=32)||150 ppm NO + SST (N=29)||160 ppm NO + SST (N=55)||All (N=198)|
- NO treatment administered intermittently was generally safe and well tolerated across the three pilot trials, with the adverse event rates similar among treatment groups.
|Trial 2||Trial 3|
|Comparison Hazard Ratio1 (p value)||Comparison Hazard Ratio1 (p value)|
|Dose||160 ppm NO vs. SST||150 ppm NO vs. SST|
|Time to Fit for Discharge||N/A2||2.32 (0.049)*|
|Hospital Length of Stay (LOS)||1.92 (0.048)*||2.28 (0.043)*|
|Time to Oxygen Saturation of ≥ 92%||2.23 (0.057)||2.62 (0.039)*|
*Met statistical significance (p<0.05) 1A hazard ratio estimate greater than one represents a higher probability of achieving success on each endpoint in the NO group relative to SST.2Time to fit for discharge was not measured in Trial 2
- Analysis across the studies demonstrated that a short course of treatments with intermittent high concentration inhaled NO (150 – 160 ppm) was effective in shortening hospital length of stay and accelerating time to fit for discharge – a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital discharge.
- Inhaled NO (150 -160 ppm) was also effective in accelerating time to stable oxygen saturation without supplemental oxygen – measured as SpO2 ≥ 92% in room air.
- In Trial 3, NO at a dose of 85 ppm NO showed no difference compared to control for all efficacy endpoints, while 150 ppm NO showed statistical significance when compared to control. Statistical significance was seen on time to fit for discharge and LOS when 150 ppm NO was compared to 85 ppm NO, while the p value for time to oxygen saturation was 0.055.
- By reducing the times to improvement in hospital length of stay, fit for discharge, and SpO2, 150 – 160 ppm NO given intermittently via inhalation demonstrates clinically meaningful efficacy for the treatment of infants with bronchiolitis.
About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. LungFit® can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit® for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
About Nitric Oxide (NO)Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
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