According to Pharmaxis, treatment has been concluded in a Phase 3 trial of its Bronchitol mannitol DPI for the treatment of cystic fibrosis. A total of 423 patients in 21 countries were treated in the 26-week randomized, double-blind parallel group study.
The company expects to report topline results in the second quarter of 2017 and, if results are positive, to submit data to the FDA with an anticipated response by the second half of 2018. The FDA issued a complete response letter for Bronchitol in March 2013 citing inadequate efficacy data from a previous trial and provided input on the design of the new trial.
Pharmaxis said that it has partnered with Chiesi on Bronchitol for the US and that Chiesi, which provided most of the funding for the trial, will be responsible for completing the Bronchitol NDA. The deal with Chiesi includes milestones of up to $25 million. Pharmaxis will manufacture Bronchitol and will keep a “high teens percent share of sales revenue.”
Pharmaxis CEO Gary Phillips commented, “Having the last of more than 400 participants at 126 sites in 21 countries complete their last clinic visit is a very significant milestone for the Bronchitol business unit. The US is the largest CF market and we are looking forward to the trial results and working to make Bronchitol available in clinics across the USA. This trial has been made possible by the clinicians, patients and CF community who have participated and we again thank them sincerely for their support.”
Read the Pharmaxis press release.
