Full Press Release Details
Positive Data from At-Home Pilot Study in Patients with
NTM Lung Infection Treated with (NO) using the LungFit GO at the CHEST Annual Meeting 2022
Data show favorable safety, tolerability, and efficacy results -
All patients titrated to 250 ppm NO with no patients needing to reduce concentration -
All patients demonstrated ability to self-administer NO at home using the easy-to-operate and
novel NO generator, LungFit GO -
City, NY, October 17, 2022 - Beyond Air, Inc. (NASDAQ: XAIR), a 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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment
of solid tumors, today announced positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients
with severe, treatment refractory, nontuberculous mycobacteria (NTM) lung disease. These data were presented in a rapid oral session
at the American College of Chest Physicians (CHEST) Annual Meeting 2022, which is being held from October 16th to 19th
are pleased to announce that data from the pilot study of the LungFit GO for NTM show favorable outcomes across safety, tolerability,
and efficacy endpoints. In addition to further supporting development of intermittent high dose NO for the treatment of NTM, this study
breaks new ground in the development of NO therapy by successfully showing the ability of our at-home generator-based system to be used
safely and consistently by this patient population in a real-world setting," commented Steve Lisi, Chairman and Chief Executive
Officer of Beyond Air. "These data give us confidence that we can move forward as FDA guidance for an NTM pivotal study is to have
a patient reported outcome, such as quality of life, for the primary endpoint with supporting secondary endpoints such as a reduction
LungFit GO is an impressive, simple to use system and very convenient for patients outside of the hospital setting," stated Dr.
Rachel Thomson MBBS, PhD, FRACP; Professor at University of Queensland, School of Medicine. "Nitric Oxide added to antibiotic therapy
shows great promise in treating NTM patients, and I look forward to a larger confirmatory study to potentially bring patients a safer
and more efficacious option."
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 (75%), a distribution consistent with real-world NTM disease. Four separate strains of NTM were represented across subjects. 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 10-week at-home treatment period of the study, a total of 2,492 inhalations were self-administered
with overall high treatment compliance (>90%). There were no serious adverse events (SAE) related to treatment discontinuations reported
over the 12-week treatment or 12-week follow up periods.
efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical
function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed as shown in the chart
below with statistical significance achieved at the 113/114 day timepoint. One subject achieved culture conversion with three consecutive
negative sputum samples.
of Life -Bronchiectasis (QOL - B (NTM)) Assessments
* The percentage of subjects improved/remain unchanged
at Day 85. The denominator for the percentages is the number of subjects with both a non-missing baseline value and a non-missing value
Mean change from baseline on the semiquantitative
for mycobacterial culture growth
*Mean score on the semiquantitative scale for mycobacterial culture
growth of 3.2 at baseline
GO NTM Trial Design.
12-week, multi-center, open-label clinical trial was 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 at the same NO level.
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.
Air is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its 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 has received
FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is currently advancing
its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as community-acquired viral
pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally, Beyond
Cancer, 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.
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.
mycobacteria (NTM) infection is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated
with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM
lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation, 13% of U.S. cystic fibrosis patients
had a positive culture for a NTM species in 2017. NTM is considered an emerging public health concern worldwide because of its multi-drug
antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics dosed chronically for as long as two
years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium abscessus complex (MABSC)
and refractory Mycobacterium avium complex (MAC) and have the potential to cause severe adverse events. Beyond Air's system is
designed to deliver 150 - 400 ppm NO to the lungs, and early data, including from the pilot study of the LungFit GO, indicate that
this range of NO concentrations could have a positive effect on patients infected with NTM.
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. 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.
Air's LungFit GO is a portable device that weighs only ~20 lbs. and operates with a standard electrical outlet (120-240 volts).
Since NO is generated from ambient air that flows through a reaction chamber, there is an unlimited supply. Beyond Air's proprietary
NO2 filters are required for the system to generate and safely deliver NO. Toxic levels of NO2 can result from high concentrations of
NO without proper filtration. The filters are equipped with an RFID chip which programs the system with respect to NO concentration,
flow rate and duration of therapy. The Company believes this design provides maximum flexibility for NO administration. Filters are single
use and there are no special requirements for disposal. Alarms monitor system performance.
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.
press release contains "forward-looking statements" concerning inhaled nitric-oxide and the Company's LungFit
product, including statements with regard to potential clinical and 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
hospitals 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