Pulmatrix Announces First Patient Dosed in Phase 2b Study of PUR1900 for Treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in Subjects with Asthma
Pulmatrix, Inc. (NASDAQ: PULM) announced the dosing of the first patient in a Phase 2b clinical trial for PUR1900, an inhaled treatment for Allergic Bronchopulmonary Aspergillosis (ABPA) and asthma. This double-blind, placebo-controlled study will assess the safety and efficacy of PUR1900 over 16 weeks, followed by an 8-week observation period. The trial aims to enroll 30 subjects across the U.S., U.K., Australia, and France. This milestone supports Pulmatrix's collaboration with Cipla and targets proof-of-concept data by mid-2024, potentially establishing PUR1900 as the first approved treatment for ABPA.
- First patient dosed in the Phase 2b trial for PUR1900.
- Potential to become the first approved treatment for ABPA.
- Collaboration with Cipla to enhance therapy delivery.
- None.
The 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 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.
Dr.
About Allergic Bronchopulmonary Aspergillosis (ABPA)
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
About
About iSPERSE™ Technology
Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.
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