The UK Medicines and Healthcare Products Regulatory Agency has approved a Clinical Trial Application filed by Pulmatrix for a Phase 1/1b study of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company said.
In October 2017, Pulmatrix announced that PUR1900 received QIDP status for that indication; the dry powder itraconazole formulation received QIDP status for the treatment of ABPA in CF patients in January 2017.
The Phase 1/1b study will include 3 study arms, with single and multiple ascending dose arms in up to 42 healthy volunteers and a study arm comparing a single dose of Pulmazole to a single dose of oral itraconazole in 16 patients with mild to moderate asthma. Top line results are expected by mid-year.
Pulmatrix Chief Medical Officer James Roach commented, “We have begun to screen subjects and look forward to initiating dosing in our first clinical trial for Pulmazole in early February. There is a significant unmet medical need in patients with both asthma and ABPA, and we believe that by delivering higher doses of itraconazole directly to the lungs while minimizing systemic exposure, Pulmazole has the potential to provide significant advantages in both efficacy and safety relative to oral itraconazole.”
CEO Robert Clarke said, “The approval to initiate clinical dosing of Pulmazole is an important step for Pulmatrix in 2018. We expect an ambitious year advancing development of both Pulmazole and PUR1800 as part of our core company strategy, while continuing progress on our US partnership of the PUR0200 once daily bronchodilator program with Vectura.”
Read the Pulmatrix press release.
