Pulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma.
The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second quarter of 2020.
The trial will include four arms of 16 participants apiece, according to Pulmatrix, and will study the safety and tolerability of multiple-dose administration of PUR1900. The company also plans to assess the pharmacokinetics of multiple-dose administration of inhaled PUR1900 in plasma and sputum.
Pulmatrix is also slated to evaluate the effect of PUR1900 on biomarkers of inflammation, pulmonary function, asthma symptoms and aspergillus burden in sputum.
“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,” CEO Robert Clarke said in prepared remarks.