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Beyond Air® Reports Positive Long-Term Safety Data for High Concentration Inhaled Nitric Oxide in Bronchiolitis at the Pediatric Academic Societies Meeting 2022
来源: Nasdaq GlobeNewswire / 25 4月 2022 16:05:00 America/New_York
GARDEN CITY, N.Y., April 25, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive long-term safety data for high concentration inhaled NO for the treatment of bronchiolitis. These data were included in an oral presentation at the Pediatric Academic Societies 2022 Meeting (PAS 2022), which is being held April 21-25 in Denver, Colorado.
The multi-center study for longitudinal data collection was designed to evaluate the long-term effect of inhaled NO treatment in infants who participated in three pilot studies conducted between 2012-2020. These three randomized, double blind clinical trials were conducted with intermittent high dose inhaled NO of 85-160 ppm for acute bronchiolitis or oxygen/air (control), administered in addition to standard supportive treatment (SST). A total of 198 infants participated in the three studies, with 101 infants participating in the long-term follow-up study. Previously announced data from all three of these studies showed a favorable short term safety profile as well as strong trends for efficacy. No inhaled NO-treatment related serious adverse events (SAEs) or severe AEs were reported, and the incidence level for severe AEs was similar among all groups. Study endpoints for the long-term safety study included percentage of subjects re-hospitalized for bronchiolitis related reasons, such reasons included wheezing episodes, pneumonia, asthma, etc., and the percentage of subjects re-hospitalized for any reason.
Data from the study, presented in the tables below, show the re-hospitalization rate per 100 Patient Exposure Years (PEY) due to bronchiolitis related reasons trended favorably for the inhaled NO group. In addition, the long-term subject re-hospitalization rate for any reason was similar between inhaled NO and control groups. As such, the study concludes that the treatment of hospitalized infants with acute bronchiolitis by intermittent high dose inhaled NO show a favorable long-term safety profile.
Subjects re-hospitalized for bronchiolitis related outcomes
Treatment/Control Group Subjects re-hospitalized (N) Total Subjects (N) Incidence Rate (95%CI) (%) PEY* Rate per 100 PEY (95%CI) SST 6 39 15.39
(5.86 to 30.53)143.0 4.20
(1.60 to 8.33)85 ppm iNO + SST 1 24 4.17 38.0 2.63 150 ppm iNO + SST 1 20 5.00 32.4 3.09 160 ppm iNO + SST 2 18 11.11
(1.38 to 34.71)90.6 2.21
(0.27 to 6.90)*PEY=Patient Exposure Years, It is anticipated that the follow-up time when subjects completed the original studies to this current study will be different for different subjects. It is, therefore, necessary to calculate the patient year (PEY) which is the summation of the time (in years) from original study completion date to date of participation in the current study
Subjects re-hospitalized for any reason
Treatment/Control Group Subjects re-hospitalized (N) Total Subjects (N) Incidence Rate (95%CI) (%) PEY* Rate per 100 PEY (95%CI) SST 8 39 20.51
(9.30 to 36.46)143.0 5.59
(2.54 to 9.95)85 ppm iNO + SST 5 24 20.83
(7.13 to 42.15)38.0 13.16
(4.50 to 26.62)150 ppm iNO + SST 2 20 10.00
(1.24 to 31.70)32.4 6.17
(0.76 to 19.57)160 ppm iNO + SST 3 18 16.67
(3.58 to 41.42)90.6 3.31
(0.71 to 8.23)*PEY=Patient Exposure Years, It is anticipated that the follow-up time when subjects completed the original studies to this current study will be different for different subjects. It is, therefore, necessary to calculate the patient year (PEY) which is the summation of the time (in years) from original study completion date to date of participation in the current study
“We are pleased to announce new long-term safety data which further support the development of nitric oxide as a therapy for bronchiolitis or similar acute treatment settings, such as community-acquired viral pneumonia (CAVP). A proposed pivotal study of high concentration inhaled NO to treat bronchiolitis or CAVP using our LungFit® Pro system is expected to begin in the fourth quarter of 2023,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The Beyond Air team continues to execute in this challenging pandemic environment and move the Beyond Air pipeline forward.”
“These long-term data confirm the positive safety profile of treating acutely with high concentration NO and a larger, confirmatory efficacy study is warranted in this patient population as soon as possible, as this is an area of immediate medical need,” stated Aviv Goldbart, M.D. Professor, Head of Department Pediatrics, Soroka University Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Dr. Goldbart presented the results of the long-term study at the PAS 2022 Meeting in an oral presentation titled, “1179165 – Long-term effects of inhaled nitric oxide in infants with bronchiolitis – a multi center study”. The presentation is available on the Events page of the Beyond Air website (click here).
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 acute viral pneumonia (including COVID-19) 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 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® 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 or use at home.
About Bronchiolitis
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 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 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: the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidate; the impact of the COVID-19 pandemic on the FDA’s review process; our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or 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 early 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.CONTACTS:
Maria Yonkoski, Head of Investor Relations
Beyond Air, Inc.
Myonkoski@beyondair.netCorey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
