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Beyond Air® Initiates Patient Screening for LungFit™ GO Pilot Study for At-Home, Self-Administration of Inhaled Nitric Oxide in Nontuberculous Mycobacteria Lung Disease
Expect to dose first patient in January 2021 and report interim data mid-2021 Success in nontuberculous mycobacteria (NTM) at-home study paves the way to
About this update from Beyond Air, Inc.
[{"type":"text","content":"Expect to dose first patient in January 2021 and report interim data mid-2021 Success in nontuberculous mycobacteria (NTM) at-home study paves the way to enter the much broader market treating severe lung infections in the home GARDEN CITY, N.Y., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage 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 gaseous NO for the treatment of solid tumors and tumor metastases, today announced that it initiated screening patients for its at-home pilot trial with LungFit™ GO for the treatment of NTM lung disease. The 12-week, multi-center, open-label clinical trial is taking place in Australia and will enroll approximately 20 adult patients with chronic refractory NTM lung disease. The trial will enroll both cystic fibrosis (CF) and non-CF patients infected with Mycobacterium avium complex (MAC) or Mycobacterium abscessus complex (MABSC). The Company expects to dose the first patient in January 2021, report interim data mid-2021, and release the full data set approximately six months later. The trial consists of a run-in period followed by two treatment phases. The run-in period will provide a baseline for the efficacy endpoints, such as patient physical function and bacterial load. The first treatment phase will take place over a two week period and begin in the hospital setting where patients will be titrated from 150 parts per million (ppm) NO up to 250 ppm NO over several days. During this phase patients will receive NO for 40 minutes, four times per day while methemoglobin and nitrogen dioxide (NO2) levels are monitored. Patients will be trained to use LungFit™ GO then subsequently discharged to complete the remaining portion of the two week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administrations will be twice daily. The study will evaluate safety, quality of life, physical function, and bacterial load among other parameters, as compared to baseline measurements. “The Beyond Air team continues to execute with the initiation of this trial, which brings us one step closer to being able to offer an a...