Beyond Air, Inc. (XAIR) Reports Positive Study Update from the At-Home LungFit GO Pilot Study

Beyond Air, Inc. (NASDAQ: XAIR) today announced positive new interim data from the ongoing LungFit® GO pilot at-home study in Australia.

In this study, patients self-administered high concentration inhaled NO at home to treat severe nontuberculous mycobacterial (NTM) lung disease. These data were included in a poster presentation at the American Thoracic Society International Conference 2022 (ATS 2022), which is being held in San Francisco from May 13-18, 2022. The Company expects complete safety and efficacy results to be reported later in 2022.

At the time of the data cutoff on April 4, 2022, a total of 15 subjects were enrolled in the pilot study. The mean age of subjects was 62.1 years (range: 22–82 years) with the majority female (80%), a distribution consistent with real-world NTM disease.

The data show that high concentration inhaled NO was well tolerated following a total of 2,323 inhalations self-administered at home with no treatment related discontinuations reported and overall high treatment compliance. All 15 subjects were successfully titrated to 250 ppm NO in the hospital setting, and none have required dose reductions during the subsequent at-home portion of the study. Methemoglobin and NO2 concentrations remained within acceptable ranges in all subjects during NO treatment, below the safety thresholds of 10% and 5 ppm, respectively. Patients are followed up for 12 weeks after the 12-week treatment period is completed and the last patient visit at the end of week 24 will occur in August 2022. The totality of the data will be used to evaluate efficacy measures, including quality of life, physical function, and sputum bacteria as compared to baseline measurements.

“The LungFit Go pilot study has provided data that opens the door to treating patients suffering from NTM lung infection, as well as other chronic, refractory lung infections, with high concentration NO in the comfort of their own homes or anywhere there is electric power. Most importantly, in addition to the strong safety and tolerability data, patients reported quality-of-life benefits from receiving the home NO treatment in the majority of quality-of-life endpoints, with the most improved benefits being NTM symptoms and digestive symptoms,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

“The LungFit is an impressive device that may allow for the use of nitric oxide in the home setting for NTM patients. These data provide hope for these severely sick patients with limited therapeutic options, that there can be a therapy with a favorable safety and tolerability profile which will improve quality of life and may have an impact on bacteria,” stated Dr. Rachel Thomson MBBS, PhD, FRACP; Professor at University of Queensland, School of Medicine.

Dr. Thomson presented the interim results at the ATS 2022 in poster titled, “Home-based Intermittent Inhaled High-Dose Nitric Oxide (NO) in Nontuberculous Mycobacterial Pulmonary Disease Using a Novel NO Generator and Delivery System is Safe and Well-Tolerated.” The poster is available on the Publications page of the Beyond Air website (click here).

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