LUNGFIT NTM

Nontuberculous Mycobacteria (NTM)

About Non-Tuberculous Myobacteria

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.

Product Status and Market Potential

Beyond Air Active Pipeline & Market Size

Product Indication Development
Status
Key Dates* US Sales
Potential**
Worldwide Sales
Potential**
LungFitNTM
(Severe Lung
Infections)
NTM
(nontuberculous
mycobacteria)
13 patients treated

2nd pilot study to have higher ppm NO and MAC infection
2020 start for at home pilot study with self-administration

Launch 2024*
>$1b >$2.5b

*All dates are based on projections and appropriate financing, anticipated first launch on global basis pending appropriate regulatory approvals

**All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential

New Care for an Underserved Market

NTM is an FDA disease area of focus with limited options. Beyond Air is initially targeting NTM abscessus (MABSC), the most aggressive and difficult to treat form of NTM.

There are a limited number of companies undertaking human studies for the treatment of NTM. Beyond Air expects to seek approval in NTM MAC (mycobacterium avium complex) following MABSC approval.

180,000+

estimated NTM cases in the U.S. in 20141

$1.7 billion

estimated NTM costs, with MABSC costs greater than 2x MAC costs1

37%

of NTM confirmed cystic fibrosis patients in the U.S. are MABSC2

20% - 25%

of all NTM cases in a South Korean database are MABSC3

13 years

median survival for MAC4

4.6 years

median survival for non-MAC NTM4

Pilot NTM Study

Pilot NTM Study

Beyond Air is planning a pilot NTM 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.

Important Safety Information

Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.