Pharmaxis Announces Results of Pivotal Bronchitol Cystic Fibrosis Clinical Trial for US Market
Release Date: 13/06/2017 9:34am
Pharmaceutical research company Pharmaxis (ASX: PXS) today announced its recently completed international Phase 3 trial of Bronchitol® (mannitol) in adults with cystic fibrosis (CF) met its primary endpoint.
- The study recruited adult CF patients with all grades of disease that were already on the best standard of care.
- The study demonstrated the superiority of Bronchitol versus the comparator on the primary endpoint (FEV1 change from baseline over 26 week treatment period), with an effect of 54 ml (p=0.020), corresponding to a 2.2% relative change (p=0.025).
- The improvement in lung function was less than that seen in the adult CF population in previously reported phase 3 studies.
- No statistically significant differences between treatment groups in secondary endpoints were recorded, although a trend was observed in favour of Bronchitol for another lung function parameter (FVC).
- Bronchitol had a good safety profile with similar rates of adverse events seen compared to control.
- FDA resubmission is expected in 2018.
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