Pulmatrix has announced the initiation of a Phase 2b trial of its PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma. In 2020, PUR1900 received fast track designation for that indication. Pulmatrix is partnered with Cipla subsidiary Cip Tec on development of the itraconazole DPI, which it has previously called “Pulmazole.”
According to the company, the study is expected to enroll 30 patients with ABPA and asthma who will receive either 20 mg PUR1900, 40 mg PUR1900, or placebo every day for 16 weeks. After dosing is complete, the study will continue with an 8-week observation period.
Pulmatrix CEO Ted Raad commented, “The dosing of our Phase 2 study is an important milestone for Pulmatrix and supports our partnership with Cipla to bring this important therapy to patients with ABPA and asthma. Initiating this study this quarter as planned, allows us to maintain our momentum towards expected proof-of-concept data by mid-2024.”
Chief Medical Officer Margaret Wasilewski said, “Starting our patient dosing of PUR1900 is a very exciting achievement for Pulmatrix. PUR1900 has the potential to prevent the dose-limiting side effects of oral antifungal treatments, while delivering more drug to the site of infection, in the lungs. This study will assess the efficacy of PUR1900 in patients with asthma and ABPA, which we believe is an important advancement since PUR1900 has the potential to become the first treatment approved for this patient population.”
Read the Pulmatrix press release.
