Important Safety Information
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.
Nontuberculous Mycobacteria (NTM)
Nontuberculous Mycobacteria (NTM) comprise of more than 160 species of bacteria that are found naturally in the environment. The most common species causing disease is called Mycobacterium avium complex (MAC). The next most common are Mycobacterium abscessus and Mycobacterium kansasii. Everyone inhales NTM into the lungs but people with existing lung diseases such as bronchiectasis, COPD, CF, alpha-1 antitrypsin deficiency or with primary or secondary immunodeficiencies are at higher risk of developing pulmonary NTM disease. Treatment of NTM infections usually requires long term use of a combination of two to three antibiotics and is limited by the potential toxicity of multiple side-effects.
Nontuberculous Mycobacterium abscessus (Mabs) lung infection is a rare but serious pulmonary disease associated with increased morbidity and mortality. This is the most aggressive and difficult to treat form of NTM. Beyond Air proprietary in-vitro data shows a promising potential synergic effect between antibiotics given for treatment of NTM and high-dose intermittent NO. Longer exposure to NO could be required for bacterial killing in a subset of Mabs strains. Beyond Air’s proprietary nitric oxide formulation yielded positive clinical results in humans in its single-arm pilot NTM study.
Pilot NTM At-Home Study
Beyond Air is planning a pilot NTM at-home study in Australia to start in Q2 2020. The study will include 20 CF and non-CF patients with refractory MAC and M abs infections. In addition to their standard treatment, the patients will receive intermittent inhalations with NO 4 times a day for the first 14 days and 2 times a day for the next 10 weeks. Patients will receive NO of up to 250 ppm depending of tolerability. The study aims to obtain preliminary data on the safety and efficacy of intermittent NO given in doses of up to 250 ppm.
LungFit GO
Resources to Learn More
- Non Tuberculous Mycobacteria (NTM) Overview
- FDA Workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease: Event Materials
- FDA Workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease: Transcript
- FDA: Development of Antibacterial Drugs for NTM: A Regulatory Perspective
- New data on RSV Burden and Management
- Regulatory Aspects of Drug Development for Nontuberculous Mycobacteria Pulmonary Infections
- Epidemiology of Pulmonary Nontuberculous Mycobacterial Disease
- FDA: Public Meeting on Non-Tuberculous Mycobacterial (NTM) Lung Infections Patient – Focused Drug Development
- Quality of Life – Nontuberculous Mycobacteria (NTM) Module
- The Voice of the Patient
- Why Do I (and so many others) Have NTM Lung Infections?
- AIT Therapeutics to Present Data from Its Inhaled Nitric Oxide Study in Patients Infected with Mycobacterium Abscessus Complex at the 2018 American Thoracic Society Conference
- Pilot study to test inhaled nitric oxide in cystic fibrosis patients with refractory Mycobacterium abscessus lung infection