Pulmatrix sought approval of its Clinical Trial Application from MHRA for Pulmazole

Clinical stage Biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, Pulmatrix sought approval of its Clinical Trial Application from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to commence its first-in-human  study for Pulmazole (PUR1900), an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients.

ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus growing in the airways. This phase 1/1b study will be conducted in healthy subjects and patients with mild to moderate stable asthma.  The study will include single ascending dose (SAD) and multiple ascending dose (MAD) arms in normal healthy volunteers (NHV) to assess safety, tolerability, and pharmacokinetics (PK).

James Roach,MD.,Chief Medical Officer of Pulmatrix claimed “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.”