Pulmatrix can now begin to test in second phase its anti-fungal drug itraconaole inhaled iSPERSE formulation, to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma, after the US FDA approved the company’s Investigational New Drug (IND) Application.
The company said Thursday in the press release that the Phase 2 Study will check Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis. The study will mainly focus on multiple-dose administration of PUR1900 given to adult asthmatic subjects with ABPA.
Top line data is expected in the second quarter of 2020.
Secondary objectives include test the effect of PUR1900 on relevant biomarkers of inflammation, pulmonary function, asthma symptoms, and aspergillus burden in sputum, the company said.
Robert Clarke, Pulmatrix CEO, said:“We are very pleased that the FDA review of the IND is complete allowing us to proceed and this important regulatory milestone reinforces Pulmatrix’s intention to bring an improved novel therapeutic option to patients suffering from ABPA. This is a critical step in the progression of Pulmazole to bring the product to patients in the US.”
by Dino Mustfić