Pulmatrix has reported positive results from a Phase I/Ib trial of pulmazole (PUR1900) for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients.
The three-part open-label trial enrolled a total of 58 patients.
Parts one and two saw both the single and multiple ascending doses of pulmazole administered daily to the healthy adults for a period of 14 days to examine the safety, tolerability, and pharmacokinetics (PK) of the drug.
Part three assessed the safety, tolerability, and PK of pulmazole, which was given as a single-dose in mild-to-moderate asthmatic patients.
An additional exploratory objective was included in part three to identify the concentrations of itraconazole in induced sputum following single doses of inhaled pulmazole and oral sporanox solution in mild to moderate stable asthma patients.
Results showed that pulmazole was safe and well-tolerated in healthy subjects at doses of up to 35mg.
They also successfully demonstrated the safety and tolerance of a single dose of pulmazole 20mg and oral sporanox 200mg in asthmatic subjects.
The most common adverse event (AE) observed was mild cough during dosing, while no subject experienced an AE resulting in withdrawal.
Pulmatrix chief medical officer Jim Roach said: “With the Phase I study results now firmly in hand, we remain very enthusiastic about the potential for pulmazole to address the significant limitations associated with oral itraconazole, and more importantly, to address the significant unmet medical need that patients with asthma and ABPA currently face.
“We believe that these results strongly support the further advancement of pulmazole into Phase II and look forward to getting our next study underway next month.”
Pulmazole is an inhaled pry-powder iSPERSETM formulation of the anti-fungal drug itraconazole developed by pulmatrix as a potential treatment of ABPA in patients with asthma.