Inspire Announces Positive Results from Phase 3 Clinical Trial of Denufosol
June 6, 2008
Inspire Pharmaceuticals, Inc. announced today positive results from a Phase 3 clinical trial of denufosol, an inhaled therapy for the treatment of CF. Denufosol is designed to improve chloride transport in the airways and enhance mucus hydration and clearance.
The study, called TIGER-1, involved 352 patients over a 24-week period. It showed significantly improved lung function in patients taking the drug. The data from this trial is particularly encouraging because it brings the CF community one step closer to a novel treatment that addresses the basic defect in CF.
“The results from this trial are exciting because they demonstrate that denufosol’s mechanism of action, activation of an alternative chloride channel that helps to hydrate and clear mucus from the lungs, had a clinically-meaningful impact on lung function,” said Frank J. Accurso, M.D., director of the Cystic Fibrosis Center and professor of pediatrics at the University of Colorado School of Medicine in Denver, and lead investigator of the TIGER-1 study.
Unlike drugs in the Foundation’s pipeline that address the basic defect by correcting the faulty CF protein, denufosol treats this defect by using an alternative chloride transport channel to allow sodium and chloride to move in and out of the cell.
Denufosol is the result of work that has been supported by the Foundation for more than 17 years, beginning with a grant from the Research Development Program to the University of North Carolina at Chapel Hill. This support enabled Richard Boucher, M.D., a researcher at UNC, to understand the science of alternate chloride channels, leading to the development of denufosol.
“The Foundation has worked closely with Inspire from the beginning of this program and provided funding for a key Phase 2 clinical trial. This validates our business model to support highly innovative potential new treatments for CF, and provides even more hope and optimism for people with cystic fibrosis,” said Robert J. Beall, Ph.D., president and CEO of the Foundation.
TIGER-1 is the first of two Phase 3 trials conducted by Inspire. The second Phase 3 trial, TIGER-2, is currently enrolling 350 patients for a 24-week trial. Read more about participating in the TIGER-2 denufosol trial.
“We want to extend a special thank you to the hundreds of patients who participated in the first Phase 3 trial of denufosol,” said Beall. “Because of your participation, we’re able to move therapies to the marketplace that truly make a difference in the lives of those with CF.”
Read the full press release.