Pulmatrix, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to PUR1900 ('Pulmazole'), the Company’s inhaled itraconazole antifungal candidate being developed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. Pulmatrix is currently enrolling patients in its ongoing randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, pulmonary function and biomarker response of Pulmazole in subjects with asthma-ABPA. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent interaction and communication with the FDA on matters pertaining to the drug’s development plan as well as eligibility for accelerated approval and priority review. However, Fast Track designation does not guarantee that a drug candidate will receive FDA approval in a timely manner, or at all. The Phase 2 study is a global, multicenter, 4 arm trial. Enrolled subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each (n=64 total) and will receive 10 mg, 20 mg, or 35 mg of Pulmazole or placebo, administered via dry powder inhalation once daily for 28 days. The primary objective of the study is to evaluate the safety and tolerability of multiple-dose administration of Pulmazole given to adult subjects with asthma and ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled Pulmazole in plasma and sputum, as well as evaluating the effect of Pulmazole on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum.