20 July 2018 - - Lexington, Massachusetts-based pulmonary disease inhaled therapeutics developer Pulmatrix, Inc. (NASDAQ: PULM) has completed all dosing and follow up visits for Part 3 of the ongoing first-in-human study of Pulmazole (PUR1900), an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma, the company said.
The main objectives of the study in Part 3 were to evaluate the safety, tolerability, and pharmacokinetics of Pulmazole administered as a single-dose in mild-to-moderate asthmatics.
Pulmazole was safe and well tolerated administered as a single-dose of 20 mg inhaled itraconazole in asthmatic subjects. Based on review of the top-line preliminary data, the study successfully achieved all objectives.
In the pharmacokinetic analysis of the data available, maximum sputum itraconazole concentrations were approximately 50-fold higher following inhalation dosing of 20 mg of Pulmazole compared to oral Sporanox dosing of 200 mg.
High lung exposure following inhalation of a single dose of 20 mg Pulmazole was maintained over a 24-hour period, whereas sputum concentrations of itraconazole decreased between 2 hours and 6 hours after a single 200 mg oral Sporanox dose.
Total systemic exposure over 24 hours (AUC0-24h) and maximum plasma concentration were approximately 85-fold and 250-fold lower compared to AUC0-24h and Cmax following 200 mg of oral Sporanox, respectively.
All study drug-related adverse events (AEs) were characterized as mild, and no moderate, severe or serious study drug-related AEs were reported. The most common AEs in Part 3 following administration of Pulmazole were mild and transient headache, and the infrequent occurrence of a mild cough.
Pulmatrix is developing innovative inhaled therapies to address serious pulmonary disease.
The company's proprietary product pipeline is focused on advancing treatments for rare diseases, including severe asthma, cystic fibrosis, COPD. Pulmatrix's product candidates are based on iSPERSE, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.