Pulmatrix has dosed the first patient in a Phase I/Ib clinical trial of Pulmazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
The trial includes healthy subjects and patients with mild to moderate stable asthma.
It will also feature single ascending dose (SAD) and multiple ascending dose (MAD) arms in normal healthy volunteers (NHV) to evaluate safety, tolerability, and pharmacokinetics (PK).
In addition, a third study arm will be conducted to assess safety and tolerability in patients with mild to moderate stable asthma. It will comprise PK analysis of itraconazole levels in the blood and sputum following administration of a single dose of oral itraconazole or Pulmazole in a crossover study design.
The trial expects to include up to 42 subjects in the SAD/MAD evaluation in NHV and 16 asthmatic patients in the crossover study. The company expects that top-line results will be available in mid-2018.
Pulmatrix chief medical officer Jim Roach said: “In addition to generating the requisite safety and tolerability data from this study to advance dosing of Pulmazole into asthmatic patients with ABPA, we anticipate that the collective pharmacokinetic data obtained in Phase I will further corroborate the key PK preclinical findings reported last week at the eighth Advances Against Aspergillosis Conference in Lisbon, Portugal, namely, that Pulmazole can provide higher lung exposure and lower systemic exposure than oral Sporanox.”
Pulmatrix’s Pulmazole (PUR1900) is an inhaled iSPERSE dry powder formulation of the anti-fungal drug itraconazole designed to treat ABPA in asthma patients.