Bronchitol results in cystic fibrosis

Pharmaxis announced results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis. The two studies were of similar design and encompass 643 patients from 11 countries. Over the 26 weeks of the two studies, patients treated with Bronchitol had an average 7.3% improvement in lung function (FEV1) compared to baseline and a significant improvement compared to patients in the control group. In the sub group of patients who were also on rhDNase, patients taking Bronchitol showed a 5.3% improvement from baseline , that was again superior to the control group. In the sub group of patients who were not on rhDNase, patients taking Bronchitol showed a 9.44% improvement from baseline that was also superior to the control group. The overall rate per annum reduction in exacerbations for patients on Bronchitol versus those on control was 25% (NS) and the number of patients experiencing an exacerbation was 29% lower for those taking Bronchitol. Analysts were not impressed as the drug improved lung function but did not meet its primary endpoint.In the CF 302 study the drug showed a good safety profile. Pharmaxis are based at Frenchs Forest, NSW, Australia.