Beyond Air® Publishes Peer-Reviewed Journal Article in Scientific Reports with Clinical Data Showing Nitric Oxide was Safe and Beneficial Adjunct Therapy for Subjects with Viral Pneumonia
Beyond Air (NASDAQ: XAIR) has published a peer-reviewed article in Scientific Reports, demonstrating the safety and benefits of nitric oxide (NO) as an adjunct therapy for viral pneumonia. The study, conducted on COVID-19 patients, showed that 150-ppm intermittent inhaled NO administered with the LungFit® PRO device was well-tolerated and beneficial compared to usual care. Key findings include:
1. Mitigation of viral pneumonia severity
2. Enhanced recovery with reduced time to reach stable room air saturation
3. Shortened duration of supportive oxygen need
The company views these results as promising for further investigation of inhaled NO in treating viral and bacterial lung infections. Beyond Air is currently focusing on commercializing LungFit PH for treating term and near-term neonates with hypoxic respiratory failure.
Beyond Air (NASDAQ: XAIR) ha pubblicato un articolo sottoposto a revisione paritaria su Scientific Reports, dimostrando la sicurezza e i benefici dell'ossido nitrico (NO) come terapia aggiuntiva per la polmonite virale. Lo studio, condotto su pazienti con COVID-19, ha mostrato che il NO inalato intermittente a 150 ppm somministrato con il dispositivo LungFit® PRO è stato ben tollerato e ha apportato benefici rispetto alle cure standard. I risultati chiave includono:
1. Mitigazione della gravità della polmonite virale
2. Recupero migliorato con un tempo ridotto per raggiungere la saturazione dell'aria ambiente stabile
3. Durata ridotta del bisogno di ossigeno di supporto
L'azienda considera questi risultati promettenti per ulteriori indagini sull'uso dell'NO inalato nel trattamento delle infezioni polmonari virali e batteriche. Beyond Air è attualmente concentrata sulla commercializzazione di LungFit PH per il trattamento di neonati a termine e pretermine con insufficienza respiratoria ipossica.
Beyond Air (NASDAQ: XAIR) ha publicado un artículo revisado por pares en Scientific Reports, que demuestra la seguridad y los beneficios del óxido nítrico (NO) como terapia adjunta para la neumonía viral. El estudio, realizado en pacientes con COVID-19, mostró que el NO inhalado intermitente a 150 ppm administrado con el dispositivo LungFit® PRO fue bien tolerado y beneficioso en comparación con el tratamiento habitual. Los hallazgos clave incluyen:
1. Mitigación de la gravedad de la neumonía viral
2. Recuperación mejorada con un menor tiempo para alcanzar la saturación del aire ambiente estable
3. Duración reducida de la necesidad de oxígeno de apoyo
La empresa considera que estos resultados son prometedores para investigar más sobre el NO inhalado en el tratamiento de infecciones pulmonares virales y bacterianas. Beyond Air se centra actualmente en la comercialización de LungFit PH para tratar a neonatos a término y cercanos a término con insuficiencia respiratoria hipóxica.
비욘드 에어(Beyond Air)(NASDAQ: XAIR)는 과학 보고서(Scientific Reports)에 동료 검토된 기사를 게재하여 바이러스성 폐렴에 대한 보조 요법으로서 일산화질소(NO)의 안전성과 이점을 입증했습니다. COVID-19 환자를 대상으로 한 연구는 150-ppm 간헐적 흡입 NO가 LungFit® PRO 장치로 투여되었을 때 일반적인 치료에 비해 잘 견디며 유익하다는 것을 보여주었습니다. 주요 발견 사항은 다음과 같습니다:
1. 바이러스성 폐렴 중증도 완화
2. 안정적인 실내 공기 포화에 도달하는 시간 단축에 따른 회복 증진
3. 보조 산소 필요 기간 단축
회사는 이 결과가 바이러스 및 세균성 폐 감염 치료에 있어 흡입 NO의 추가 조사를 위한 유망한 결과로 보고 있습니다. 비욘드 에어는 현재 저산소성 호흡 부전을 겪고 있는 만기 및 근만기 신생아 치료를 위해 LungFit PH 상용화에 집중하고 있습니다.
Beyond Air (NASDAQ: XAIR) a publié un article évalué par des pairs dans Scientific Reports, démontrant la sécurité et les avantages du monoxyde d'azote (NO) comme thérapie adjuvante pour la pneumonie virale. L'étude, réalisée sur des patients atteints de COVID-19, a montré que le NO inhalé intermittente à 150 ppm administré avec le dispositif LungFit® PRO a été bien toléré et bénéfique par rapport aux soins habituels. Les principales conclusions comprennent:
1. Atténuation de la gravité de la pneumonie virale
2. Amélioration de la récupération avec une réduction du temps nécessaire pour atteindre une saturation stable en air ambiant
3. Durée réduite du besoin d'oxygène de soutien
L'entreprise considère ces résultats comme prometteurs pour une enquête plus approfondie sur l'utilisation de NO inhalé dans le traitement des infections pulmonaires virales et bactériennes. Beyond Air se concentre actuellement sur la commercialisation de LungFit PH pour traiter les nouveau-nés à terme et proches du terme avec une insuffisance respiratoire hypoxique.
Beyond Air (NASDAQ: XAIR) hat einen von Fachleuten begutachteten Artikel in Scientific Reports veröffentlicht, der die Sicherheit und die Vorteile von Stickstoffmonoxid (NO) als ergänzende Therapie bei viraler Pneumonie demonstriert. Die Studie, die an COVID-19-Patienten durchgeführt wurde, zeigte, dass 150-ppm intermittierendes inhalatives NO, verabreicht mit dem LungFit® PRO-Gerät, gut vertragen wurde und im Vergleich zur üblichen Behandlung nützlich war. Wichtige Ergebnisse umfassen:
1. Minderung der Schwere der viralen Pneumonie
2. Verbesserte Genesung mit verkürzter Zeit, um stabile Raumluft-Sättigung zu erreichen
3. Verkürzte Dauer des Bedarfs an unterstützendem Sauerstoff
Das Unternehmen sieht diese Ergebnisse als vielversprechend für weitere Untersuchungen von inhalativem NO zur Behandlung viraler und bakterieller Lungeninfektionen. Beyond Air konzentriert sich derzeit auf die Kommerzialisierung von LungFit PH zur Behandlung von termingerechten und nahen Neugeborenen mit hypoxischer Ateminsuffizienz.
- Publication of peer-reviewed article in Scientific Reports, enhancing credibility
- Demonstrated safety and efficacy of nitric oxide therapy for viral pneumonia
- Potential for expanded use of inhaled NO in treating various lung infections
- Ongoing commercialization of LungFit PH for neonatal hypoxic respiratory failure
- None.
Insights
The publication of Beyond Air's clinical data in Scientific Reports marks a significant milestone in the evaluation of nitric oxide (NO) as a potential treatment for viral pneumonia. The study's findings, demonstrating that 150-ppm intermittent inhaled NO is well-tolerated, safe and beneficial compared to usual care, are particularly noteworthy.
Key takeaways from the study include:
- Potential mitigation of viral pneumonia severity
- Enhanced recovery, with reduced time to reach stable room air saturation
- Shorter duration of supportive oxygen requirement
These results are promising for several reasons:
1. Expanding treatment options: In the context of viral pneumonia, where treatment options can be , a safe and effective adjunct therapy could significantly improve patient outcomes.
2. Versatility of NO: The study reinforces the potential of nitric oxide in treating various respiratory conditions, which could lead to broader applications of Beyond Air's LungFit® technology.
3. Safety profile: The demonstrated safety of high-dose inhaled NO is important for potential regulatory approvals and clinical adoption.
However, it's important to note that this study focused on COVID-19-related viral pneumonia. Further research will be needed to confirm these benefits in other types of viral or bacterial pneumonia. Additionally, the company's immediate focus on commercializing LungFit PH for neonatal hypoxic respiratory failure suggests that the infectious disease program may not be an immediate priority.
Overall, this publication strengthens Beyond Air's scientific credibility and could potentially attract more interest from the medical community and investors. However, the path from promising clinical data to commercial success in new indications is often long and uncertain.
The publication of Beyond Air's clinical data in a peer-reviewed journal is a positive development for the company, but its immediate financial impact may be Here's why:
1. Validation of technology: The positive results provide scientific validation for Beyond Air's nitric oxide delivery system, which could enhance investor confidence in the company's technology platform.
2. Potential market expansion: The data suggests possible applications in treating viral pneumonia, which could represent a significant market opportunity. However, it's important to note that substantial additional research and development would be required before commercialization in this indication.
3. Focus on current commercialization: The CEO's statement indicates that the company's primary focus remains on commercializing LungFit PH for neonatal hypoxic respiratory failure. This suggests that any financial benefits from the viral pneumonia application are likely long-term rather than immediate.
4. Research and development pipeline: The positive results may justify further investment in the company's infectious disease program, potentially increasing R&D expenses in the future.
5. Potential partnerships: The publication could attract interest from potential partners or collaborators in the infectious disease space, potentially leading to future licensing or partnership agreements.
From an investor's perspective, while this news is encouraging for Beyond Air's long-term prospects, it's unlikely to have a significant impact on near-term financials. The company's success in the short to medium term will likely depend more on the commercial performance of LungFit PH in its current approved indication.
Investors should monitor the company's progress in its core commercialization efforts, as well as any announcements regarding plans to advance the infectious disease program based on these results.
GARDEN CITY, N.Y., July 31, 2024 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”), today announced the publication of its scientific article, “A safety evaluation of intermittent high-dose inhaled nitric oxide in viral pneumonia due to COVID-19: a randomized clinical study” in Scientific Reports, an online peer-reviewed journal from the publishers of Nature. The article is freely available online at https://www.nature.com/articles/s41598-024-68055-w.
Talya Wolak, M.D., The head of Internal Medicine Department D at Shaare Zedek Medical Center, Jerusalem, Israel, stated, “We are pleased to publish these promising data showing 150-ppm intermittent inhaled NO administered with the LungFit® PRO device is well-tolerated, safe, and beneficial compared to usual care in treating adults hospitalized for viral pneumonia due to COVID-19. Specifically, treatment with high dose inhaled NO may mitigate viral pneumonia severity and enhance a subject’s recovery by reducing time to reach stable room air saturation and duration of supportive oxygen.”
“I am pleased to see the publication of this article in Nature’s Scientific Reports and gain broader awareness of these promising data in treating viral pneumonia with inhaled NO,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “These data will support further investigation of inhaled NO for treating viral and bacterial lung infections, as it demonstrates clinical benefits and safety in this high risk population. We continue to be excited by the variety of benefits inhaled NO provides the human body and will continue to focus on ramping up our commercial program for the LungFit PH to treat term and near-term neonates with hypoxic respiratory failure prior to moving our infectious disease program forward.”
About Beyond Air®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM) among others. Also, the Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., 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
Nitric Oxide 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®*
Beyond Air’s LungFit is a cylinder-free, phasic flow 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 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. 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 to treat term and near-term neonates with hypoxic respiratory failure. 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.
About Viral Community-Acquired Pneumonia (VCAP)
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.
Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “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 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 views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
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