According to Mast Therapeutics, the University of Pittsburgh will conduct a Phase 1/2 open-label safety and proof of concept clinical trial of AIR001 sodium nitrite inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Mast subsidiary Aires Pharmaceuticals will get rights to the data but is providing no support other than the drug and nebulizers.
In August 2016, Mast announced the initiation of a Phase 2 study of AIR001 for the treatment of heart failure with preserved ejection fraction (HFpEF), and the company is also developing AIR001 for the treatment of pulmonary hypertension.
Mast Therapeutics Chief Medical Officer Edwin L. Parsley commented, “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. The antimicrobial activity of nitrite increases under anaerobic and acidotic conditions such as those found in the CF airways, and in non-clinical studies, AIR001 has been shown to prevent P. aeruginosa biotic biofilm growth on the surface of primary CF airway cells.”
CEO Brian M. Culley said, “We are excited that CF experts at University of Pittsburgh wish to study the therapeutic potential of AIR001 in this patient population. We believe this initiative opens an entirely new area of potential clinical and commercial opportunity for AIR001 and enjoys synergy with the pipeline of our anticipated reverse merger partner, Savara Inc.”
Read the Mast Therapeutics press release.
