150 ppm nitric oxide was statistically significant compared to both control and 85 ppm nitric oxide arms on the primary and key secondary endpoints
All treatment groups had similar safety profiles and nitric oxide was well tolerated with no drug-related serious adverse events observed
GARDEN CITY, N.Y., Oct. 19, 2020 — 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 and tumor metastases, today announced the presentation of data from its bronchiolitis program at the CHEST Annual Meeting 2020, which is being held virtually from October 18th to 21st.
Aviv Goldbart, MD, Head, Department of Pediatrics, Soroka Medical Center that presents the bronchiolitis pilot study poster, stated, “We are excited by the data presented today, as they support the development of inhaled NO as a vasodilator, bronchodilator, an anti-inflammatory and anti-microbial agent. This new approach could be an effective and safe new treatment option of viral lower respiratory tract infections, including bronchiolitis or COVID-19.”
The bronchiolitis pilot study analyzed data from 87 infants across eight medical centers. Subjects were randomized 1:1:1 to standard supportive therapy (SST), 150 parts per million (ppm) NO + SST and 85 ppm NO + SST. Study treatment was given for 40 minutes, every 4.5 hours (±30 min), four times per day for up to five days. Results from the study show that the effects of intermittent inhaled NO at 150 ppm were statistically significant compared to both standard therapy and 85 ppm NO in reducing the primary endpoint of time to fit for discharge and the key secondary endpoints of hospital length of stay (LOS) and time to oxygen saturation of > 92%. There were no significant differences observed between the 85 ppm NO arm and SST on any endpoint. All treatment groups had similar safety profiles showing that NO therapy was generally well tolerated with no serious adverse events related to NO therapy.
|150 ppm vs. 85ppm
Hazard Ratio (p-value)
|150 ppm vs. SST
Hazard Ratio (p-value)
|Fit for Discharge*|
|2.11 (0.041)||2.32 (0.049)|
|Hospital Length of Stay (LOS)|
|2.01 (0.046)||2.28 (0.043)|
|Oxygen Saturation of 92%|
|2.15 (0.0555)||2.62 (0.0392)|
*Fit for Discharge is a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital discharge.
“This third consecutive successful study in infants hospitalized with viral lung infections provides the evidence we need to move forward with a definitive study to establish the efficacy and safety of nitric oxide generated and delivered via our LungFit™ system,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Once again the Beyond Air team has executed well and I look forward to our continued success.”
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. 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 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.
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 US 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™ is not approved for commercial use. Beyond Air’s LungFit™ is for investigational use only. Beyond Air is not suggesting NO use over 80 ppm nor 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 over 80 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 regulatory developments, the potential impact on patients 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 approach to discover and develop novel devices and drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; 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; the successful development of our product candidates, all of which are in various stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history 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.
Steven Lisi, Chief Executive Officer
Beyond Air, Inc.
Maria Yonkoski, Head of Investor Relations
Beyond Air, Inc.
Corey Davis, Ph.D.
LifeSci Advisors, LLC