Pulmatrix, Inc. announced that it has received authorization of its Clinical Trial Application from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate its first-in-human study for Pulmazole (PUR1900), an inhaled iSPERSE™ formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus growing in the airways. Oral itraconazole (Sporanox®) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. This phase 1/1b study will be conducted in healthy subjects and patients with mild to moderate stable asthma. The study will include single ascending dose (SAD) and multiple ascending dose (MAD) arms in normal healthy volunteers (NHV) to assess safety, tolerability, and pharmacokinetics (PK). A third study arm will evaluate safety and tolerability in patients with mild to moderate stable asthma and will also include PK analysis of itraconazole levels in the blood and sputum following administration of a single dose of oral itraconazole (Sporanox; 200 mg itraconazole) or Pulmazole (20 mg itraconazole) in a crossover study design. This program represents the first inhaled dry-powder formulation of itraconazole that the Company is aware of to enter clinical development. The study is planned to include up to 42 subjects in the SAD/MAD evaluation in NHV and 16 asthmatics in the crossover study. The company expects that top line results will be available in mid-2018.