Pharmaxis Announces Results of Pivotal Bronchitol Cystic Fibrosis Clinical Trial for US Market

13th Jun 17

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.

Read full media release - pdf

Categories: News and Media