Mast Therapeutics (NYSE:MSTX) said today that its subsidiary Aires Pharmaceuticals inked a deal with the University of Pittsburgh related to its phase 1/2 open-label proof-of-concept trial for the company’s AIR001 inhaled sodium nitrite solution in patients with cystic fibrosis.
The study will evaluate the nebulized drug as a treatment of Pseudomonas aeruginosa infection in CF patients, according to Mast. The subsidiary plans to provide the drug and nebulizers for the study, but no financial support.
“We are excited that CF experts at University of Pittsburgh wish to study the therapeutic potential of AIR001 in this patient population,” Mast CEO Brian Culley said in prepared remarks. “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.”
The study aims to determine the safety of AIR001 given in a dose escalation manner to adults with CF and an airway infection. Researchers also plan to evaluate the effects of the inhaled drug relating to lung function, exhaled airway nitric oxide and bacterial density.
According to the agreement with the university, the company can use the de-identified data and results for regulatory submissions.
“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,” Mast chief medical officer Edwin Parsley added. “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.”
In January, Mast and privately-held Savara Inc. landed a definitive merger agreement, combining their operations. The newly-formed Austin, Texas-based company is expected to be named Savara Inc., and trade on the NYSE market under a new ticker symbol.
The combined company will focus on advancing a pipeline of inhaled therapies, including AeroVanc to treat chronic methicillin-resistant Staphylococcus aureus pulmonary infection in cystic fibrosis, Molgradex to treat pulmonary alveolar proteinosis and AIR1001 to treat heart failure with preserved ejection fraction. All 3 treatments are in advanced clinical development.