Pulmatrix activates sites for Pulmazole Phase 2 clinical study
Pulmatrix announces that three sites in the United States have been activated for the Phase 2 clinical investigation for Pulmazole - an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma. The three activated sites are able to recruit, screen and enroll patients. The study has regulatory approval in the United States, United Kingdom and Australia which account for 17 of the study's 25 treatment sites. Pulmatrix is pursuing regulatory approval for the in India and Poland, which will account for the remaining 8 treatment sites. The Phase 2 study is a global, multicenter, 4 arm trial. Enrolled subjects will be randomly assigned into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via once daily dry powder inhalation 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 asthmatic subjects with ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled PUR1900 in plasma and sputum, as well as evaluating the effect of Pulmazole on relevant biomarkers of inflammation, pulmonary function, asthma symptoms, and aspergillus burden in sputum. Top line data is expected in mid 2020.