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Beyond Air® Announces Positive Data from At-Home Pilot Study in Patients with Refractory 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
About this update from Beyond Air, Inc.
[{"type":"text","content":"-- 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 compact novel NO generator, LungFit GO -- GARDEN CITY, N.Y., Oct. 17, 2022 (GLOBE NEWSWIRE) -- 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 in Nashville, TN. “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,” 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 in bacterial load.” “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, 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.” A...