Australia's Pharmaxis says that Bronchitol, its experimental cystic-fibrosis drug, met its primary and secondary goal in a late-stage study. Researchers said the drug delivered a statistically significant improvement in lung function. Lung function improved at week six and was sustained through week 26.
Researchers said that Bronchitol also improved lung function in patients taking Pulmozyme, a Genentech therapy launched 15 years ago. Pharmaxis says that the data will keep the company on track to file for an approval later this year, noting that no new therapies for cystic fibrosis have been approved in the last 10 years. Bronchitol has orphan drug status in the U.S. and Europe.
"In a trial which recruited a wide range of patients with varying disease severity, Bronchitol showed significant health benefits," said Pharmaxis CEO Alan Robertson. "As the first dry powder formulation to publish positive results in cystic fibrosis it promises convenience for patients who have complex daily schedules dominated by difficult treatment regimens."
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