Pulmatrix has announced that its Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has received Fast Track designation from the FDA. The company initiated a Phase 2 trial of Pulmazole for that indication in July 2019.
Pulmatrix CEO Ted Raad said, “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. We view this FDA Fast Track designation as continued support that Pulmazole, enabled by Pulmatrix’s iSPERSE delivery technology, has the potential to advance towards a first line treatment option for ABPA patients. 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.”
A co-lead investigator of the Phase 2 study, William J Calhoun of the University of Texas Medical Branch, commented, “Approximately half of ABPA patients do not respond to first line treatment with oral steroids which carry risks of dependence and complications from long-term use. While effective, second-line oral antifungals are limited in their use due to safety and tolerability concerns. Pulmazole, which is being tested as an inhaled antifungal, has shown promising Phase 1/1b study results enabling approximately 50-fold higher lung delivery at 1/10th the dosing of oral itraconazole. I believe Pulmazole has the potential to shift the standard care for ABPA by addressing the underlying cause of inflammatory responses while avoiding the significant limitations in efficacy and safety associated with oral steroid and antifungal standard of care treatment.”
Read the Pulmatrix press release.
