The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis.
Patients with ABPA are usually given oral itraconazole as an adjunctive treatment to corticosteroids, but the drug is limited thanks to its poor bioavailability and variable pharmacokinetics, according to Pulmatrix. The company hopes that by delivering itraconazole directly to the lung, it can improve upon the drug’s safety and efficacy profile.
The Phase I/Ib study plans to enroll healthy participants and patients with mild to moderate asthma. In the single ascending dose and multiple ascending dose arms of the trial, which are slated to include up to 42 people, Pulmatrix will assess Pulmazole’s safety, tolerability and pharmacokinetics. In a 16-person crossover cohort, the company hopes to conduct pharmacokinetic analyses in patients given a single dose of oral itraconazole or inhaled itraconazole.
“Dosing our first subject with Pulmazole and entering the clinic represents a major milestone for this program,” chief medical officer Dr. Jim Roach said in prepared remarks.
“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 1 will further corroborate the key PK preclinical findings reported last week at the 8th Advances Against Aspergillosis Conference in Lisbon, Portugal – namely, that Pulmazole can provide higher lung exposure and lower systemic exposure than oral Sporanox.”
Top-line results from the study will be available later this year, Pulmatrix reported.
“The initiation of our Pulmazole clinical trial is important validation of our iSperse dry powder technology as the second program to advance into the clinic along with PUR0200,” CEO Robert Clarke added. “We look forward to advancing Pulmazole and our iSperse pipeline to improve the treatment approaches for patients with unmet medical needs.”