2025
BMC Pulmonary Medicine (2025). https://doi.org/10.1186/ s12890-025-04090-1
Preclinical assessment of long-term safety of nebulized BromAc®
Mucpharm Pty Ltd., Sydney, NSW 2217, Australia Department of Surgery, St George Hospital, Sydney, NSW 2217, Australia St George & Sutherland Clinical School, University of New South Wales, Sydney, NSW 2217, Australia Intensive Care Unit, St George Hospital, Sydney, NSW 2217, Australia
Service type: Stock strains
Abstract
BromAc® is a novel therapeutic agent under investigation for its potential in treating respiratory diseases. Evaluating its safety profile following inhalation is crucial for future clinical application. Here, we evaluated BromAc® safety in a long-term inhalation study. Forty BALB/c mice were divided into five groups (N=8 each): sham control, saline control, and three BromAc® dose groups at 0.250/20, 0.500/20, and 0.750/20 mg/mL, respectively. Treatments were administered by inhalation three times daily for 28 days. A final single dose was given on Day 29 before euthanasia. Various parameters were assessed during the study to evaluate the effect of BromAc such as wellbeing and bodyweight, along with tissue pathology and inflammatory cytokine assessment. The results indicated that inhalation of BromAc® over 28 days did not affect general health, behavior, or body weight compared to control. No signs of respiratory distress, hemorrhage, hypoxia, or any other disorders were observed. Mild, nondose-dependent lung pathology and inflammatory changes were observed across all groups including control. Cytokine analysis revealed nonsignificant differences between treated and control groups. Hence, these findings suggest that BromAc® is safe for inhalation at the tested concentrations and duration.
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