Pulmatrix, Inc. (NASDAQ: PULM) announces today that three sites in the United States have been activated for the Phase 2 clinical investigation for Pulmazole (PUR1900) – an inhaled iSPERSE^TM formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) 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.

“We are excited to announce the initiation of our Phase 2 Pulmazole trial,” said Ted Raad, Pulmatrix’s chief executive officer.  “With our Clinical Advisory Board of ABPA experts, we developed a meaningful clinical trial that will help inform the treatment of this debilitating disease and further advance the Pulmazole program.”

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 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 (FEV1), asthma symptoms, and aspergillus burden in sputum.  Top line data is expected in mid 2020.

About Pulmatrix  
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis (“ABPA”), and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease (“COPD”). Pulmatrix’s product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.