Pulmatrix has announced the initiation of a Phase 2 clinical trial of Pulmazole inhaled itraconazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma, with top line data expected in mid 2020. Cip Tech acquired rights to Pulmazole for this indication earlier this year, in a deal conditioned on Pulmatrix’s ability to fund the Phase 2 study.
Patients enrolled in the Phase 2 safety and tolerability study will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo via DPI over 28 days. The trial will also evaluate PK the effects of PUR1900 on inflammation, lung function, asthma symptoms, and aspergillus burden.
The company said that it has opened 3 out of an eventual total of 25 treatment sites. According to Pulmatrix, regulatory approval is still being sought in India and Poland, which will account for 8 of the treatment sites. The remaining sites will be in the US, UK, and Australia, where the company has already obtained approval for the trial.
Pulmatrix CEO Ted Raad commented, “We are excited to announce the initiation of our Phase 2 Pulmazole trial. With our clinical advisory board of ABPA experts, we developed a meaningful clinical trial that will help inform the treatment of this debilitating disease and further advance the Pulmazole program.”
Read the Pulmatrix press release.
