GARDEN CITY, N.Y., Oct. 03, 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, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today 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://www.atsjournals.org/doi/10.1513/AnnalsATS.202103-348OC.
“We’re pleased to have published the positive clinical results from our third pilot study of the inhaled NO to treat bronchiolitis in infants in the Annals of the ATS. The results of this study show that high dose inhaled NO given intermittently may be useful in treating patients with moderate to severe bronchiolitis, and supports the need to conduct a larger, confirmatory efficacy study. As previously announced, due to the lingering effects of the pandemic, our bronchiolitis program is on hold and we plan on initiating a study of high concentration inhaled NO to treat viral community-acquired pneumonia (VCAP) using our LungFit® Pro system in the fourth quarter of 2023, pending discussions with the FDA,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The lack of an effective treatment, with an acceptable safety profile, that shortens the course of hospitalization or hastens symptom resolution for infants with moderate-severe bronchiolitis or for patients suffering from community-acquired pneumonia with a viral infection is the major driver behind our push to continue to develop the LungFit Pro for this immediate medical need.”
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.
About Beyond Air, Inc.
Beyond Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its 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. The 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 has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as community-acquired viral pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally, Beyond Cancer, an affiliate of Beyond Air, is investigating 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.
About the LungFit®*
Beyond Air’s LungFit® is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The LungFit® system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. The LungFit® can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.
* Beyond Air’s LungFit® PH is approved for commercial use only in the United States of America. Beyond Air’s other LungFit® systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.
The majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air’s system is designed to effectively deliver 150 – 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi, and other microbes from the lungs.
Forward Looking Statements
This press release contains “forward-looking statements” concerning inhaled nitric-oxide and the Company’s LungFit® product, including statements with regard to potential clinical and regulatory developments and the expected timing thereof, expected product launch for the Company’s LungFit® product and the timing thereof, and the potential impact on patients and hospitals and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “impacts,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our ability to successfully commercialize LungFit® PH in the U.S. in the planned timeframe; our ability to achieve a CE mark for LungFit® PH in the European Union; the risk that LungFit® PH may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives; intense competition and rapid technological changes may adversely affect our ability to successfully commercialize LungFit® PH; if we are unable to establish sales and marketing capabilities or enter into agreements with third-parties to market and sell LungFit® PH, we may be unable to generate any revenue; LungFit® PH may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for LungFit® PH may be smaller than we estimate; our ability to fund and the results of pre-clinical and clinical trials for our product candidates; obtaining, maintaining and protecting intellectual property utilized by our product and product candidates; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; obtaining regulatory approval for our product candidates; our short operating history; risks related to the COVID-19 pandemic and their effect on our business; and other risks identified and described in more detail in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
Corey Davis, Ph.D.
LifeSci Advisors, LLC