Biopharmaceutical company Pulmatrix has received the go-ahead from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to start a first-in-human clinical trial of its innovative inhaled formulation of the antifungal drug, itraconazole. The dry-powder version of drug was developed using Pulmatrix’s proprietary iSPERSE platform to change the mode of drug delivery.
The inhaled form of itraconazole – dubbed Pulmazole – was developed to treat allergic bronchopulmonary aspergillosis (ABPA), a condition which most often occurs in patients with asthma or cystic fibrosis. Patients with ABPA suffer from allergic hypersensitivity to Aspergillus, a fungus which can grow in the lungs and airways.
Sporanox, an oral version of itraconazole, is already in use to support the action of corticosteroids in lessoning the immune response in patients with ABPA, however its use is limited. The oral drug has poor bioavailability and holds the risk of gastrointestinal and cardiac side effects.
“We have begun to screen subjects and look forward to initiating dosing in our first clinical trial for Pulmazole in early February,” commented Dr. James Roach, Chief Medical Officer of Pulmatrix. “There is a significant unmet medical need in patients with both asthma and ABPA, and we believe that by delivering higher doses of itraconazole directly to the lungs while minimizing systemic exposure, Pulmazole has the potential to provide significant advantages in both efficacy and safety relative to oral itraconazole.”
The Phase 1 trial will enroll both healthy volunteers and patients with mild to moderate asthma. Both single ascending dose (SAD) and multiple ascending dose (MAD) arms will be used to assess the safety, tolerability and pharmacokinetics profile of the inhaled antifungal in the healthy subjects.
Single doses of both Sporanox and Pulmazole will be tested in the patients with mild to moderate stable asthma to compare the safety and tolerability of the different forms of the drug. According to Pulmatrix, Pulmazole is the first inhaled dry-powder formulation of itraconazole to undergo clinical development.
In all, up to 42 healthy subjects will be included in the study, along with 16 individuals with asthma. Results of the trial are expected to be available as early as mid-2018.