BEYOND AIR, INC.
'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
'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
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
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.
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
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 LungFit*
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.
About Acute Viral Pneumonia
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.
About COVID-19
COVID-19 (coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 first emerged in December of 2019. Those affected develop fever, cough, shortness of breath and/or difficulty breathing. While the majority of cases result in mild symptoms, some can progress to pneumonia and multi-organ failure. Older adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from COVID-19. There is no specific treatment approved for COVID-19 and patients are managed with supportive care. 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 process1,2,3. As of
[1] Tripathi et al, FEMS Immunology and Medical Microbiology,
[2] Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.
[3] Akerstrom 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, 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 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
Contact:
Chief Executive Officer
E: Slisi@beyondair.net
Head of Investor Relations
E: Myonkoski@beyondair.net
E: Cdavis@lifesciadvisors.com
T: (212) 915-2577
(C) 2021 Electronic News Publishing, source
