Pharmaxis Completes Phase 3 Trial Of Bronchitol
Pharmaxis, a specialist pharmaceutical company, has completed second six month, Phase 3 international trial assessing the effectiveness of Bronchitol in people with cystic fibrosis.
The double blind, placebo controlled, randomised study comparing 400mg of Bronchitol twice a day to control included 305 participants, and was conducted across 53 sites in 7 countries. Pharmaxis said that the last participant has completed the final clinical visit and the trial has run on time and on budget.
Pharmaxis has now completed blinded efficacy and safety period, an optional 26 week open-label uncontrolled Bronchitol extension is still running.
The trial is the second of two trials in cystic fibrosis, required by the FDA, before a marketing application can be submitted in the US. A total of 600 cystic fibrosis patients have now been recruited into the two Bronchitol Phase 3 clinical trials.
The primary efficacy end-point is change in lung function from baseline as determined by FEV1 (forced expiratory volume in one second) over 26 weeks. The results of the trial is expected to be available shortly after data review and statistical analysis of the various endpoints have been completed.
Pharmaxis said that the trial has been designed under the FDA’s Special Protocol Assessment (SPA) scheme. Pharmaxis has received Orphan Drug Designation and fast track status from the FDA for Bronchitol in cystic fibrosis.
Based on the results of the first Phase III trial reported in May 2009, Pharmaxis had filed a marketing authorisation application with the European Medicines Agency in October 2009. The regulatory review is expected to conclude during the second half of 2010.
Alan Robertson, CEO of Pharmaxis, said: “We are very pleased to announce this important milestone. The support of the US Cystic Fibrosis Foundation has been important in conducting this trial efficiently and there has been considerable enthusiasm from patients and the clinical centres involved. It is hoped this trial will confirm that Bronchitol has the opportunity to impact the way people with cystic fibrosis live their lives.”