Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients’ Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home

Rhea-AI Summary

Beyond Air (NASDAQ: XAIR) has published promising results from its pilot study of the LungFit™ GO device for treating Nontuberculous Mycobacterial (NTM) pulmonary disease in the Annals of the American Thoracic Society journal.

The 12-week multi-center trial, supported by the U.S. Cystic Fibrosis Foundation, enrolled 15 patients with chronic refractory NTM lung disease. Patients successfully self-administered high-dose nitric oxide (NO) treatments at home with over 90% compliance rate. The study demonstrated that patients could safely self-administer up to 250 ppm NO treatments with no serious adverse events or treatment discontinuations.

Key findings include:

• High compliance with over 2,400 self-administered inhalations
• Meaningful improvements in quality of life domains
• Maintained respiratory and physical function
• Trends showing reduction in microbial load
• One subject achieved culture conversion during follow-up

Positive

• High patient compliance (>90%) with over 2,400 successful self-administered treatments
• No serious adverse events or treatment discontinuations reported
• Demonstrated safety profile with successful titration to 250 ppm NO
• Meaningful improvements in quality of life metrics
• Evidence of reduced microbial load and one patient achieving culture conversion

Negative

• Small sample size of only 15 patients
• Study not powered to detect statistically significant efficacy improvements
• Further larger pivotal studies needed to confirm results

Insights

Biotech Clinical Analyst

Beyond Air's publication in the Annals of the American Thoracic Society represents encouraging clinical progress for their LungFit GO device. The pilot study demonstrates that patients with Nontuberculous Mycobacterial pulmonary disease (NTM-PD) can safely self-administer high-dose inhaled nitric oxide at home with remarkable >90% compliance.

The data from 15 subjects shows a favorable safety profile with no serious adverse events leading to discontinuation, alongside quality of life improvements particularly in respiratory symptoms. The observed reduction in microbial load and one case of culture conversion (absence of bacterial growth) are promising efficacy signals for this difficult-to-treat condition.

What makes this approach particularly noteworthy is its potential as an alternative therapy for NTM infections, which increasingly show resistance to conventional antibiotics. The ability for patients to self-administer treatment at home addresses a significant practical hurdle in managing chronic respiratory conditions.

However, investors should recognize this remains an early-stage pilot study "not powered to detect statistically significant improvement in efficacy." The Cystic Fibrosis Foundation's support lends credibility, but larger pivotal trials will be necessary to definitively establish efficacy and support potential regulatory approval for this indication.

GARDEN CITY, N.Y., April 09, 2025 (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 nitric oxide (NO) to improve the lives of patients, today announced the publication of its scientific article, “A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide as Treatment of Nontuberculous Mycobacteria Lung Infection” in Annals of the American Thoracic Society, an online peer-reviewed journal. The article is available online at (click here).

“Nontuberculous mycobacterial pulmonary disease is a significant clinical problem worldwide, as we are seeing an increasing number of treatment resistant strains and frequent intolerance of antibiotics. In this pilot study, the delivery of high dose iNO treatments at home revealed high compliance with a favorable safety profile, potential quality of life improvement, and decreased culture score implying a decrease in mycobacterial load. While this study was not powered to detect a statistically significant improvement in efficacy, we believe the results support the potential value of iNO as an additional novel anti-NTM agent and should be evaluated further in a larger pivotal study,” stated Professor Rachel Thomson, Head of the Greenslopes Clinical Unit, Thoracic Physician and clinical researcher working at Greenslopes Private Hospital.

“We are excited to have data from the study of LungFit GO published in the well-respected ATS journal. This article is expected to gain broader awareness of these promising data in treating chronic refractory NTM with inhaled NO,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “These data show clinical benefits and safety in this high-risk population and support further evaluating inhaled NO delivered using the LungFit GO for treating NTM infections.”

The LungFit GO NTM Trial (NCT04685720) was a 12-week, multi-center, open-label clinical trial supported by a grant from the U.S. Cystic Fibrosis Foundation and took place in Australia for adult subjects with chronic refractory NTM lung disease. The trial enrolled both cystic fibrosis (CF) and non-CF subjects chronically infected with Mycobacterium avium complex (MAC), Mycobacterium abscessus complex (MABSC) or other strains of NTM who are refractory to standard therapies. The trial consisted of a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints, such as patient physical function and bacterial load. The first treatment phase took place over a two-week period and began in the hospital setting where subjects were titrated from 150 ppm NO up to 250 ppm NO over several days. During this first treatment phase subjects received NO for 40 minutes, four times per day while methemoglobin and nitrogen dioxide (NO2) levels were monitored (monitoring in-hospital only). Subjects were trained to use the LungFit GO and were subsequently discharged to complete the remaining portion of the two-week treatment period at their home, continuing the established highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the inhalation treatments were administered twice daily at250 ppm NO. Subjects were evaluated for an additional 12 weeks after the end of treatment. The study evaluated safety, tolerability, quality of life, physical function, and bacterial load among other parameters, as compared to baseline measurements.

A total of 15 subjects were enrolled in the pilot study with a mean age of 62.1 years (range: 22-82 years), the majority of which were female (80%), a distribution consistent with real-world NTM disease. Four separate strains of NTM were represented across subjects at baseline. All subjects were successfully titrated to 250 ppm NO in the hospital setting, and none required dose reductions during the subsequent at-home portion of the study. There were no occurrences of methemoglobinemia and no subjects discontinued NO therapy due to nitrogen dioxide (NO₂) concentrations. During the 11-week at-home treatment period of the study, more than 2,400 inhalations were self-administered with overall high treatment compliance (>90%). There were no treatment related discontinuations due to serious adverse events (SAE) over the 12-week treatment or 12-week follow up periods.

Key efficacy endpoints showed strong results with signs of meaningful improvement (reported minimum important difference) noted in a subset of subjects across all Quality of Life domains particularly respiratory symptoms, NTM symptoms and emotional functioning. Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed at the 113/114 day timepoint as measured by a semi-quantitative culture score. One subject experienced culture conversion as indicated by the absence of mycobacterial growth at two timepoints during the off-treatment phase.

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 and CE Mark 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).

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 LungFit®*

Beyond Air’s LungFit® is a cylinder-free, phasic flow generator and delivery system 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 by eliminating NO2 purging steps, and offering other operational 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 in the United States, European Union, Australia, Thailand and New Zealand. 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 Nitric Oxide

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-cardiac surgery, 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.

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

FAQ

What were the key results of Beyond Air's LungFit GO NTM trial for XAIR stock?

The trial showed >90% compliance rate, safe self-administration of 250 ppm NO, quality of life improvements, and reduced microbial load, with no serious adverse events reported.

How many patients participated in Beyond Air's (XAIR) NTM clinical trial?

15 subjects with a mean age of 62.1 years participated in the trial, with 80% being female.

What was the duration and structure of XAIR's LungFit GO clinical trial?

The trial consisted of a 12-week treatment period (2-week initial phase and 10-week maintenance) followed by a 12-week follow-up period.

How effective was the self-administration of Beyond Air's (XAIR) LungFit GO device?

Patients successfully self-administered over 2,400 inhalations with >90% compliance rate, with no treatment-related discontinuations.