Pharmaxis starts recruiting for Bronchitol trial
Pharmaxis (ASX:PXS) has enrolled the first subject for an international phase III trial of Bronchitol in cystic fibrosis.
The trial will form part of Pharmaxis’s FDA application for the dry powder treatment candidate, and its protocol has been approved by the US agency.
The 26-week randomised, double-blind, placebo-controlled parallel group study will enrol between 350 and 440 adult cystic fibrosis patients. It will involve more than 100 sites across 19 countries. Recruitment is expected to take 12 months to complete.
Patients will be assessed for improvements in lung function, pulmonary exacerbations and safety. The trial's primary end point will be improvement in forced expiratory volume (FEV1) from baseline over the 26-week treatment period.
“This phase III trial in adults has been carefully designed with the benefit of our two previous CF trials, where a post-hoc analysis of the subgroups of adult patients showed a significant improvement in FEV1,” Pharmaxis CEO Gary Phillips said.
“The design of the trial also incorporates the very clear guidance provided by the FDA concerning what is required in order to gain approval for Bronchitol in the US.”
Bronchitol is a spray-dried formulation of mannitol delivered into the lungs by a specialty portable inhaler. It already has marketing approval for adults in Europe and for patients older than five in Australia.
Pharmaxis (ASX:PXS) shares were trading 17.65% higher at $0.06 as of around 1.30 pm on Friday
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