The Cystic Fibrosis Foundation (CFF) has given Beyond Air up to $2.17 million to test its portable inhaled nitric oxide therapy for people with cystic fibrosis (CF) who have chronic, treatment-resistant lung infections caused by non-tuberculous mycobacteria (NTM).
This grant award will support a pilot clinical trial to determine the safety and effectiveness of the investigational therapy, LungFit GO (a nitric oxide generator and delivery system), used along with current treatments that include the antibiotics amikacin and azithromycin.
NTM infections are usually found in people with an underlying lung disease, such as CF, or with a compromised immune system.
These infections are difficult to treat, requiring prolonged antibiotic use. But extended use can carry significant side effects, including hearing loss, and raises the risk of antibiotic resistance.
Mycobacterium abscessus, a highly treatment-resistant NTM known to causes serious lung infections, is particularly linked with poorer lung function in CF patients.
“The treatment regimen for NTM infections can be grueling — often requiring aggressive antibiotics for up to two years,” JP Clancy, MD, vice president of clinical research at CF Foundation, said in a press release. “Creating new and better therapies that can be better tolerated and can reduce the side effect and treatment burden is particularly important for people with CF battling these difficult-to-treat bacteria.”
Nitric oxide (NO) is a powerful vasodilator — it opens blood vessels, improving blood flow — and an important mediator of immune defense mechanisms against infections, with broad-spectrum antibacterial activity. Research suggests that raising NO levels could help to rid patients of bacterial infections, improving their lung health.
Beyond Air has developed LungFit GO, a device that generates NO from ambient air and converts it into an inhalable form that can be self-administered by patients in the hospital or at home.
The device is portable, without a need for the expensive and high-pressure NO cylinders that cannot be used outside a hospital or center. It also allows for either constant or increasing doses of NO, important because higher doses would be necessary to treat NTM infections, the company states.
The open-label LungFit GO trial is enrolling 20 adults with chronic, treatment-resistant lung infections caused by Mycobacterium avium complex or Mycobacterium abscessus complex, the two most important bacterial groups leading to NTM lung disease. Eligible patients may or may not have CF.
The study is being conducted in Australia and will last 12 weeks (three months).
CFF funding is through its Infection Research Initiative, opened in 2018 to advance research into better detection, diagnosis and treatments of infections in CF patients. The foundation has committed $79 million this initiative, supporting more than 15 related programs.
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