Pulmatrix announced the first patient has been dosed in the Phase 2 trial evaluating Pulmazole, an inhaled iSPERSE formulation of the antifungal itraconazole in development for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma. The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of three dose levels of Pulmazole administered daily for 28 days in approximately 64 patients.
"Building upon the Phase 1 results, in which Pulmazole achieved greater drug concentrations in the lung with much lower plasma concentrations than oral Sporanox at 1/10th the dose, the dosing of our first Phase 2 Study patient is an important milestone," said Ted Raad, chief executive officer of Pulmatrix. "We believe that Pulmazole has the potential to change the standard of care for patients with ABPA and asthma by providing a treatment option that prevents the dose-limiting side effects seen with oral antifungal treatments and improves upon the known efficacy of oral itraconazole by delivering significantly more drug to the lungs than can be achieved with oral dosing."
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The Phase 2 study is a global, multicenter, 4 arm trial. Enrolled subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each (n=64 total) and will receive 10 mg, 20 mg, or 35 mg of Pulmazole or placebo, administered via once daily dry powder inhalation daily for 28 days. The primary objective of the study is to evaluate the safety and tolerability of multiple-dose administration of Pulmazole given to adult subjects with asthma and ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled Pulmazole in plasma and sputum, as well as evaluating the effect of Pulmazole on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum.
Allergic bronchopulmonary aspergillosis (ABPA) is an exaggerated response of the immune system to the fungus Aspergillus fumigatus in patients with asthma and cystic fibrosis. Aspergillus, a ubiquitous fungus, colonizes the airways of patients with asthma and cystic fibrosis and triggers an intense inflammatory response that results in worsening symptoms, more frequent exacerbations, and ultimately lung damage. Current treatment for ABPA consists of prolonged courses of oral corticosteroids, and oral antifungal therapy is added in patients who do not respond adequately to oral corticosteroid therapy alone. Published studies evaluating antifungal agents in patients with ABPA report some degree of improved disease control leading to the reduction of oral corticosteroid dose. However, the use of oral antifungal therapy is limited by systemic side effects and poor bioavailability in the airways. ABPA is estimated to occur in approximately 1.5% of adult patients with asthma, with about 300,000 affected individuals in the US and approximately 5 million patients with asthma worldwide.