Pulmatrix (NSDQ:PULM) said today that all dosing and follow-up visits have finished for its first-in-human study of an inhaled formulation of itraconazole as a treatment of allergic bronchopulmonary aspergillosis in people with asthma.
The inhaled iSperse formulation, called Pulmazole, was well-tolerated, according to the Lexington, Mass.-based company. Pulmatrix plans to launch a Phase II trial of its ABPA therapy in the fourth quarter this year.
In a pharmacokinetic analysis of data from its Phase I study, Pulmatrix found that itraconazole concentrations were roughly 50-fold higher following dosing of 20 mg of its Pulmazole product compared to 200 mg of oral Sporanox. Treatment with its inhaled product also brought about 24 hours of high lung exposure to itraconazole. Those who were treated with Sporanox saw their exposure to itraconazole decrease between 2 and 6 hours following a 200 mg dose.
“These data in asthmatics are very promising regarding the future potential of Pulmazole as a therapy for patients with ABPA, a disease with significant unmet medical need. Demonstration of significantly higher levels in the lung as well as significantly lower systemic exposure following inhalation of Pulmazole suggests that Pulmazole has the potential to dramatically improve upon the known safety and efficacy of Sporanox,” principal investigator Dr. Dave Singh said in prepared remarks.
Among the 17 people who were dosed in the last part of Pulmatrix’s first-in-human study, Pulmazole was found to be safe and well-tolerated, the company touted. The most common adverse events following the dosing of Pulmazole were mild and transient headaches, as well as a mild cough.
“These preliminary safety, tolerability and pharmacokinetic results from Part 3 in subjects with asthma strongly corroborate and further extend the positive findings we observed in normal healthy volunteers,” Dr. Jim Roach, Pulmatrix’s CMO, added. “Notably, itraconazole levels in the sputum of asthmatic subjects were much higher following inhaled versus oral administration, despite administering much lower doses of itraconazole via the inhaled route. This further supports the potential of Pulmazole to improve upon the efficacy observed with oral Sporanox in patients with ABPA.”