Mast Therapeutics Announces Clinical Study Of AIR001 For The Treatment Of Chronic Infection In Cystic Fibrosis Patients
"We are excited that CF experts at
"AIR001 may represent a new therapeutic approach for the treatment of chronic infection in CF patients because it has demonstrated broad in vitro antimicrobial activity against P. aeruginosa and other airway pathogens," stated
The objective of the open-label Phase 1/2 study is to determine the safety of AIR001, a sterile, proprietary sodium nitrite solution for intermittent inhalation, administered in a dose escalation manner to adults with CF and P. aeruginosa airway infection. The study also aims to explore the effects of AIR001 on measures of lung function, exhaled airway nitric oxide, and bacterial density. Under the agreement with the
About Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder that results in persistent lung infections and permanent and progressive respiratory disability. CF affects mostly the lungs, but also the pancreas, liver, kidneys, and intestines. In the lungs of CF patients, mucus plugs the airways and allows the development of bacterial biofilms, resulting in chronic infection. Such infection leads to bronchiectasis, or damaged airways, obstructive lung disease, and ultimately death from chronic respiratory failure. CF is a rare, or orphan, disease, affecting approximately 30,000 people in
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulization. Nitrite is a direct vasodilator and can be recycled in vivo to form nitric oxide (NO) independent of the classical NO synthase (NOS) pathway. Nitrite mediated NO formation has several beneficial effects, including dilation of blood vessels and reduction of inflammation and undesirable cell growth and has demonstrated encouraging results in Phase 2 clinical trials conducted to date in patients with heart failure with preserved ejection fraction (HFpEF).
In cystic fibrosis (CF), chronic airway infection results in cycles of airway inflammation and bronchiectasis that ultimately lead to early death from respiratory failure. Pseudomonas aeruginosa (P. aeruginosa) is the most common infectious pathogen in CF, and once chronic airway infection is established, P. aeruginosa becomes difficult to eradicate because of resistance mechanisms including bacterial growth in biofilms. The high metabolic activity of P. aeruginosa and with neutrophilic interaction results in biofilm growth that is largely anaerobic and which confers resistance to many antibiotics. Bacteria growing in biotic biofilms can be greater than 100-fold more resistant to antibiotics. In work by Zemke et. al., nitrite prevented 99% of biofilm growth. Notably, nitrite resulted in inhibition of P. aeruginosa growth on primary CF airway cells at concentrations achievable clinically with AIR001. The inhibitory effect of nitrite on bacterial oxygen consumption and biofilm growth did not require nitric oxide (NO) as an intermediate, as chemically scavenging NO did not block growth inhibition. These data suggest an NO-radical independent nitrosative or oxidative inhibition of respiration as the mechanism of action of nitrite on biotic biofilms. Thus AIR001 may provide a novel therapy for chronic P. aeruginosa infection in conditions such as CF and non-CF bronchiectasis.
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