Beyond Air Shares Positive Results From the LungFit GO Pilot Study

Beyond Air Inc. is touting 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. 
 
“We 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,” Beyond Air Chairman and CEO Steve Lisi said. “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 in bacterial load.”
  
Fifteen 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 nitric oxide (NO) in the hospital, 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, 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.
 
Key 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.

“The LungFit GO is an impressive, simple to use system and very convenient for patients outside of the hospital setting,” stated Dr. Rachel Thomson MBBS, Ph.D., 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.”
 
The 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.

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. 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 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 is a medical device and biopharmaceutical company dedicated to harnessing the power of NO through its 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. 
 
* 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.