Pharmaxis Plans Phase 3 Trial of CF Drug

Pharmaxis said Tuesday it plans to initiate two phase 3 trials of its potential cystic-fibrosis treatment Bronchitol.

The announcement comes after the firm met with the Food and Drug Administration and the European Medicines Agency about the drug candidate.

Pharmaxis said phase 2 results indicated Bronchitol, an inhalable dry powder administered by a handheld device, improved lung function in cystic-fibrosis patients. The endpoint of the phase 3 trials will be lung function, but the complete protocols are still being finalized.

We believe that Bronchitol is an important new treatment for cystic fibrosis patients, and look forward to working diligently with the FDA and the EMEA as we finalize the details of the Phase 3 program, said Pharmaxis Chief Executive Officer Alan Robertson.

Both the FDA and the EMEA have granted Bronchitol orphan-drug status, which in the United States is reserved for drugs that treat serious diseases affecting fewer than 200,000 people and could entitle Pharmaxis to up to seven years’ market exclusivity if the new therapy is approved.