Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT) has announced that it received Orphan Drug Designation from the FDA last fall for its AIT-CF high dose nitric oxide formulation for the treatment of lung infections in cystic fibrosis patients. The company says that its proprietary delivery system for the 160 ppm formulation “continuously monitors safety and efficacy parameters in the patient and is adaptable to treat a wide range of lung infections.”
AIT CEO Amir Avniel commented, “Receiving Orphan Drug Designation in September 2014 represents an important milestone as we continue to advance the clinical development of AIT-CF. Airway phlegm that contains bacterial colonizations and infections is the primary complication of CF. Inhalation of NO has demonstrated anti-infective, anti-inflammatory and vasodilating properties in CF patients. The results from our completed Phase 2 open label, multi-center study of CF patients over 10 years of age demonstrated the safety and efficacy of our product candidate.”
According to clinicaltrials.gov, treatment for the patients in the Phase 2 study included inhalation of the 160 ppm NO for 30 minute durations, 3 times per day for 10 working days.
Read the AIT press release.
