The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole.
The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma.
The 42-patient Phase I/Ib study is slated to assess the drug’s safety and tolerability in normal, healthy volunteers and in people with mild to moderate stable asthma.
“We have begun to screen subjects and look forward to initiating dosing in our first clinical trial for Pulmazole in early February,” Dr. James Roach, chief medical officer, said in prepared remarks. “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.”
Pulmatrix said it expects top-line results will be available from the study in mid-2018.
“The approval to initiate clinical dosing of Pulmazole is an important step for Pulmatrix in 2018,” CEO Robert Clarke added. “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.”
