Beyond Air has launched a pilot clinical trial evaluating its investigational therapy LungFit GO — inhaled nitric oxide that can be self-administrated at home — in adults with or without cystic fibrosis (CF) who have chronic, treatment-resistant lung infections caused by non-tuberculous mycobacteria (NTM).
Beyond Air expects to dose the first enrolled patient in January, share the trial’s interim data by mid-2021, and release its final data six months later. The trial was delayed due to the COVID-19 pandemic.
“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 at-home treatment option for difficult-to-treat patients who continue to experience a high level of unmet medical need despite recent progress in the field of NTM,” Steve Lisi, chairman and CEO of Beyond Air, said in a press release.
“Our goal for this pilot study is to obtain a clean safety profile at the higher NO [nitric oxid] concentration while demonstrating the benefit for NTM patients self-administering NO with LungFit GO in a home setting,” Lisi said.
People with underlying lung diseases, such as CF, chronic obstructive pulmonary disease (COPD), and bronchiolitis, are more susceptible to lung infections caused by NTM — a set of more than 160 species of bacteria found naturally in the environment. Typically treated with antibiotics, NTM infections are usually therapeutically challenging and often become chronic.
Notably, Mycobacterium abscessus, a highly treatment-resistant NTM that causes very aggressive and hard-to-treat lung infections, has been associated with a greater lung function decline and is often a contraindication to lung transplant in CF patients, meaning it could make an individual a poor candidate for such surgery.
LungFit GO is a device that generates nitric oxide, known as NO — a potent vasodilator with anti-inflammatory and antimicrobial properties — from ambient (outside) air and delivers it in a form that can be inhaled by patients in the hospital or at home. Of note, vasodilators are compounds that widen and relax blood vessels, lowering blood pressure and improving blood flow.
The device allows the delivery of inhaled NO at constant or increasing doses, and continuously or for a fixed period of time. Without high-pressure cylinders, the device is meant to be portable and convenient for patient use.
According to Beyond’s website, its proprietary LungFit delivery system was previously shown to be safe at NO levels of 150–250 parts per million (ppm). Preclinical data also showed a potential additive effect between antibiotics given to treat NTM infections and high-dose intermittent NO, suggesting a therapeutic benefit for such a combination in NTM lung disease.
The multi-center, open-label trial will evaluate LungFit GO’s safety and effectiveness in about 20 adults with chronic, treatment-resistant lung infections caused by MAC or MABSC. Patients will be recruited in Australia to participate in the pilot study.
Effectiveness goals include assessing changes in patients’ physical function, lung bacterial load, and quality of life, among others.
After enrollment, participants will undergo a battery of tests to assess their pre-treatment clinical state, which will serve as a reference point for effectiveness measures. This so-called run-in period will be followed by two treatment phases over a total of 12 weeks (about three months).
The first treatment phase, with a two-week duration, will begin in the hospital, where participants will receive increasing doses of inhaled NO (150–250 ppm) for 40 minutes, four times daily, over several days. This phase will help researchers and clinicians determine the highest tolerated dose of the treatment.
Patients will then be trained on how to use the LungFit GO, and discharged to complete the remaining portion of the two-week treatment period at home. All participants will use the highest tolerated NO dose established.
In the second phase of treatment, inhaled NO will continue to be self-administered through the LungFit GO, twice daily, for an additional period of 10 weeks (about 2.5 months).
“With success in this trial we will be able to show that NO therapy can be delivered in the home and potentially target other severe lung infections, given NO’s broad antimicrobial properties,” Lisi said.
Beoynd is also testing its LungFit delivery system as a potential treatment for other lung diseases, including bronchiolitis, COPD, and infections caused by COVID-19, with some trials already underway and others to be initiated next year. In addition, the company developed a separate NO delivery system for treating solid tumors, which is currently in preclinical testing.
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