Pulmatrix has announced that the 3rd part of its Phase 1/1b study of Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has been completed and “successfully achieved all objectives.” Results from parts 1 and 2 of the study were announced in June 2018.
According to the company, 17 patients with mild-to-moderate asthma received either a single 20 mg dose of Pulmazole by inhalation or a single 200 mg dose of Sporanox oral itraconazole. Pulmazole was found to be safe and well tolerated at that dose, and high lung exposure was maintained over 24 hours after a single inhalation with significantly lower systemic exposure over that time period compared to Sporanox.
Principal investigator Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at the University of Manchester, said, “These data in asthmatics are very promising regarding the future potential of Pulmazole as a therapy for patients with ABPA, a disease with significant unmet medical need. Demonstration of significantly higher levels in the lung as well as significantly lower systemic exposure following inhalation of Pulmazole suggests that Pulmazole has the potential to dramatically improve upon the known safety and efficacy of Sporanox.”
Pulmatrix Chief Medical Officer Jim Roach commented, “These preliminary safety, tolerability and pharmacokinetic results from part 3 in subjects with asthma strongly corroborate and further extend the positive findings we observed in normal healthy volunteers. Notably, itraconazole levels in the sputum of asthmatic subjects were much higher following inhaled versus oral administration, despite administering much lower doses of itraconazole via the inhaled route. This further supports the potential of Pulmazole to improve upon the efficacy observed with oral Sporanox in patients with ABPA.”
Roach added, “We believe we have now generated the requisite data to advance to initiation of a Phase 2 study in patients with asthma and ABPA and are planning for study initiation in the fourth quarter of this year. We look forward to submitting the Phase 1/1b study results in the next several weeks for presentation at a major scientific conference later this year.”
Read the Pulmatrix press release.
