Pulmatrix (NASDAQ:PULM) received FDA fast track designation for Pulmazole, an inhaled itraconazole antifungal for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
The safety, tolerability, pulmonary function and biomarker response of Pulmazole is currently being evaluated in a Phase 2 study in subjects with asthma-ABPA. Pulmatirx expects to report study results by the end of 2020.
“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,” Ted Raad, Pulmatrix’s CEO, said in a statement.
Dr. William Calhoun, co-lead investigator of the Phase 2 trial, said, “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.”
