The Food and Drug Administration has granted Fast Track designation to PUR1900 (Pulmazole; Pulmatrix) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
ABPA is a hypersentive lung reaction to the fungus, Aspergillus fumigatus. It most commonly affects patients who have asthma or cystic fibrosis. PUR1900 is an inhaled formulation of itraconazole that uses the Company’s proprietary iSPERSE technology to improve therapeutic distribution to the lungs. The technology is a dry powder delivery platform that allows a broad range of drugs to be formulated as small, dense, and dispersible particles.
The designation is supported by data from a phase 1/1b study of PUR1900 demonstrating an approximately 50-fold higher lung delivery at 1/10th the dosing of oral itraconazole. The Company is currently enrolling patients in an ongoing phase 2 study evaluating the safety, tolerability, and pharmacokinetics of PUR1900 for ABPA in adult asthmatic patients.
“Patients with asthma-ABPA have an urgent need for new therapeutic options that reduce the severe side effects associated with current standard of care treatments,” said Ted Raad, CEO of Pulmatrix. “With our phase 1/1b trial successfully meeting all endpoints, we are now focused on advancing our ongoing Phase 2 study, leveraging the important advantages of Fast Track designation, and look forward to reporting study results by year end.”
For more information visit pulmatrix.com.