The FDA has cleared Pulmatrix’s investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients.
In November 2018, Pulmatrix said that it planned to initiate a Phase 2 trial by the end of the year; now the company said that it expects to begin the study in the first half of this year, with top line data expected in the second quarter of 2020.
According to the company, the trial (titled “A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis) is expected to enroll 64 subjects and will compare 10 mg, 20 mg, or 35 mg of PUR1900 to placebo over 28 days.
Pulmatrix CEO Robert Clarke 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.”
Read the Pulmatrix press release.
