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Pulmatrix Announces First Patient Dosed in Phase 2b Study of PUR1900 for Treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in Subjects with Asthma
LEXINGTON, Mass., Feb. 6, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled
About this update from Pulmatrix, Inc.
[{"type":"text","content":"LEXINGTON, Mass., Feb. 6, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE™ technology, today 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.\n\n \n \n \n \n \n \n\n \nThe Phase 2 trial is designed as a randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and duration of treatment with itraconazole, administered as a dry powder for inhalation (PUR1900). The multi-center 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.\nThe 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.\nTed Raad, Chief Executive Officer of Pulmatrix, noted \"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 towards expected proof-of-concept data by mid-2024.\"\nDr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented, \"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.\"\nAbout Allergic Bronchopulmonary Aspergillosis (ABPA)Allergic bronchopulmonary aspergillosis (ABPA) is an exaggerated response of the immune system ...