Beyond Air® Presents Positive Safety and Efficacy Data for Inhaled Nitric Oxide to Treat COVID-19 at ECCMID 2022

Inhaled NO treatment in patients hospitalized with COVID-19 and other community-acquired viral pneumonia was well tolerated overall, and safe, with improved efficacy parameters as compared to standard supportive treatment

Duration of oxygen support was significantly shorter for subjects treated with inhaled NO

Trend in shortening of hospital length of stay for patients treated with inhaled NO compared to patients receiving standard supportive treatment

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 safety and efficacy data from the LungFit® PRO pilot study of high-concentration inhaled NO in Community-Acquired Viral Pneumonia (CAVP), including COVID-19.

The multi-center, open-label, randomized clinical trial in Israel enrolled a total of 40 subjects hospitalized for CAVP (SARS-CoV-2, n=39; other viruses n=1), who were 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). Enrolled patients were followed for a 180-day period. The study endpoints include safety, time on oxygen supplementation and hospital length of stay (LOS), among others. The Intent To Treat (ITT) population included 35 subjects with 16 in the inhaled NO group and 19 in the control group.

The data show that inhaled NO treatment in patients with COVID-19 and other CAVP was well tolerated overall, and safe, with improved efficacy parameters as compared to SST. These data were included in an oral presentation at the 32^nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), which is taking place from April 23-26^th as a hybrid event both onsite in Lisbon, Portugal and online.

Safety data from the study show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. There were two SAEs reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to study drug/device.

The efficacy results from the study are summarized in the table below. They show a trend of shortening LOS in favor of the inhaled NO treatment group. Duration of oxygen support, measured in-hospital and at home, was significantly shorter for inhaled NO treated subjects. In addition, of subjects with unstable oxygen saturation during hospitalization, 66.7% of inhaled NO treatment group reached stable saturation of ≥93% during hospital stay as compared to 26.7% in the SST group.

150 ppm NO + SST v. SST in CAVP (COVID-19) patients

	Hospital LOS	Time to reach SpO2 ≥ 93%	Duration of O2 support
Hazard Ratio [95% CI]	1.8 [0.7, 4.4]	5.4 [1.0, 28.8]	2.8 [1.1, 7.1]
P-value	0.1991	0.0490	0.0339

HR and p-values based on Kaplan-Meier estimates; All endpoints measured in days

“These data from the pilot study of LungFit Pro in CAVP patients show consistency of improvement demonstrated across important disease related assessments. We believe these results show that high concentration inhaled NO could be an effective treatment for patients hospitalized with COVID-19,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The data presented today at ECCMID further expand upon our growing portfolio of clinical data showing high concentration NO as a potentially safe and effective treatment for various upper and lower respiratory infections. These extensive data have proven inhaled NO has antimicrobial, anti-inflammatory and vasodilator properties.”

“These data show that inhaled NO could be a safe and effective treatment option for patients hospitalized with COVID-19. Overall, we saw a trend in reduction in length of hospital stay as well as a notable reduction in use of oxygen support for subjects in the treatment arm of this study,” stated Talya Wolak, M.D. Faculty of Medicine, Hebrew University of Jerusalem, Israel; The Internal Medicine Department D at Shaare Zedek Medical Center, Israel. “There continues to be tremendous attention paid to the emergence of new variants of COVID-19 which are posing a challenge for immunization strategies around the globe and highlight the need for effective therapeutic interventions. Given the broad anti-viral activity of NO and its strong safety profile, a larger, confirmatory study is urgently needed.”

Dr. Wolak presented the results of the study at ECCMID 2022 in an oral presentation titled, “00400 - Treatment of COVID-19 with inhaled nitric oxide using a novel nitric oxide generator”. 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 Community-Acquired Viral Pneumonia (CAVP)

In adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process^1,2,3. 

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.

Sources

1. Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017
2. Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.
3. Akerström S et al. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005; 79(3):1966-9.
   

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.net

Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577