Severe Lung Infections

High concentration NO delivery has a demonstrated safety record in people and animals with Beyond Air’s LungFit technology. In addition to being a bronchodilator, NO also has been shown to have anti-inflammatory effects and eliminate some viruses. Beyond Air have embarked on a program to address the needs of patients with severe lung infections using LungFit, starting with the immediate threat of COVID-19 (read our press release here) and Nontuberculous Mycobacteria (NTM)

About COVID-19

About COVID-19

COVID-19 (coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 first emerged in Wuhan, China in December of 2019. Those affected develop fever, cough, shortness of breath and/or difficulty breathing. While the majority of cases result in mild symptoms, some can progress to pneumonia and multi-organ failure. Older adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from COVID-19. There is no specific treatment approved for COVID-19 and patients are managed with supportive care. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process1,2,3. As of April 15, 2020, more than 2 million confirmed cases of COVID-19 and more than 125,000 deaths have been reported globally.

[1] Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017
[2] Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.
[3] Akerström S et al. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005; 79(3):1966-9.

COVID-19 Clinical Program

The LungFit™ will be used in an FDA approved open-label study to treat 20 patients between the ages of 22 and 65 years hospitalized with COVID-19. Subjects will be randomized 1:1 and treated with 80 ppm NO administered over 40 minutes, 4 times per day, in addition to standard of care (SOC) or treated with SOC alone. The primary endpoint is time to clinical deterioration as measured by the need for: 1) non-invasive ventilation: or 2) high flow nasal cannula; or 3) intubation. Other endpoints include reduction in viral load, need for supplemental oxygen, hospital length of stay, mortality, safety and various biomarkers.

Pending respective approvals, studies will be initiated in Canada and Israel that will resemble the U.S. study with the NO concentration at 150 ppm.

<em>Nontuberculous Mycobacteria</em> (NTM)

About Nontuberculous Mycobacteria

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 Pipeline & Market Size

Product Indication Development
Status
Key Dates* US Sales
Potential**
Worldwide Sales
Potential**
LungFit PRO COVID-19 Pilot studies in progress Pilot study data 2H20 N/A N/A
LungFit GO Nontuberculous mycobacteria (NTM) lung infection Pilot phase Pilot study start 4Q20

Self-administration at home
>$1B >$2.5B
LungFit GO Severe exacerbations due to lung infections in COPD patients Pre-clinical Pilot study start 2H21 >$2.5B >$6B

Nitri*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 At-Home 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.

Important Safety Information

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