Inspire Pharmaceuticals, Inc., announced today that the top-line results from a second Phase 3 clinical trial of denufosol did not demonstrate a statistically significant improvement in lung function for those on the drug as compared to the placebo after 48 weeks.

Improvement in lung function was the primary outcome measure for the trial. The Phase 3 trial included 466 patients in the United States, Australia, New Zealand and Canada. 

If the results had been positive, the data would have served as a basis for a New Drug Application (NDA) to the U.S. Food & Drug Association. 

“This is a serious disappointment to the entire CF community,” said Robert J. Beall, Ph.D., president and CEO of the Foundation. 

“We have long understood that drug development is not predictable, but we are always hopeful that promising therapies will prove effective for those with CF.  Inspire's latest data underscores the importance of our pursuing multiple new therapies that can control and cure CF.”

The Foundation currently has more than 30 drugs in its drug development pipeline, including several in late stage clinical trials that aim to treat the basic defect in CF.

Beall noted that the Foundation is “deeply indebted to the patients who participated in the denufosol trials, the caregivers who carried out the trials and the team at Inspire Pharmaceuticals for their commitment to bringing new CF therapies to patients.”