Pulmatrix announces patient dosed in phase 2b study of PUR1900 for treatment of ABPA in subjects with asthma

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Pulmatrix, Inc.  announced the first patient dosed in a phase 2b trial evaluating safety and efficacy of PUR1900 in subjects with allergic bronchopulmonary aspergillosis (ABPA) and asthma. PUR1900 is the company's iSPERSE-enabled dry powder formulation of itraconazole, developed for inhaled pulmonary delivery.

The phase 2 trial is designed as a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and duration of treatment with itraconazole, administered as a dry powder for inhalation (PUR1900). The multicenter study is expected to be conducted in the United States, United Kingdom, Australia and France. Endpoints include safety, tolerability, and potential efficacy outcomes in adult patients with asthma and ABPA.

The study has dosed the first of 30 planned study subjects. Subjects will be administered study drug daily for 16-weeks, followed by an 8-week, post-dose observation period. Patients will be randomly assigned to placebo, 20 mg PUR1900 or 40 mg PUR1900 (1:1:1) dose groups by oral inhalation.

Ted Raad, CEOof Pulmatrix, said "The dosing of our phase 2 study is an important milestone for Pulmatrix and supports our partnership with Cipla to bring this important therapy to patients with ABPA and asthma. Initiating this study this quarter as planned allows us to maintain our momentum toward expected proof-of-concept data by mid-2024."

Dr. Margaret Wasilewski, chief medical officer of Pulmatrix, said, "Starting our patient dosing of PUR1900 is a very exciting achievement for Pulmatrix. PUR1900 has the potential to prevent the dose-limiting side effects of oral antifungal treatments, while delivering more drug to the site of infection, in the lungs. This study will assess the efficacy of PUR1900 in patients with asthma and ABPA, which we believe is an important advancement since PUR1900 has the potential to become the first treatment approved for this patient population."

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 U.S. and approximately 5 million patients with asthma worldwide.

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