According to Pulmatrix, a recent Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients with asthma showed that total systemic exposure in healthy volunteers was significantly lower than historical levels for oral itraconazole and that the drug was well tolerated at all doses tested,
In the first part of the study (single ascending dose), 23 healthy volunteers received doses of 5, 10, 25, and 35 mg. The second part (multiple ascending dose), which involved 18 healthy volunteers, included 10, 20, and 35 mg doses over 14 days. Data from the third part of the study, which compared Pulmazole to Sporanox itraconazole solution in adult asthma patients, is expected to be available by mid-July of this year.
Pulmatrix CEO Robert W. Clarke said, “The trial results suggest that inhalation of itraconazole can be safe and well tolerated and may be a better approach to treating ABPA, a disease for which there are no currently approved therapies. The reduced systemic exposure combined with the safety and tolerability profile observed supports the feasibility and potential differentiated benefits associated with this route of administration to treat aspergillus-related diseases in the lungs.”
Chief Medical Officer Jim Roach added, “We are extremely pleased that upon review of the preliminary results from the normal healthy volunteer component of the study, Pulmazole was well tolerated up to the maximum dose tested. Additionally, the substantially lower systemic exposure for itraconazole following inhaled administration speaks to the potential for Pulmazole to improve upon the known safety concerns associated with oral Sporanox. We look forward to further reviewing and reporting the data from Part 3 of the study in asthmatic subjects, which included measuring itraconazole in sputum to assess relative lung exposure following administration of either oral Sporanox or Pulmazole, in the next few weeks.”
Read the Pulmatrix press release.
