INSPIRE REPORTS PROGRESS IN CYSTIC FIBROSIS PROGRAM

Inspire Pharmaceuticals has announced recent developments in its cystic fibrosis (CF) program, including three presentations made by Inspire executives at the 28th European Cystic Fibrosis Society Conference held June 22 to 25 in Crete, Greece.

Inspire has completed more than 50 percent of target enrollment in its ongoing Phase II safety study, which is a double-blind, randomized comparison of two doses of denufosol tetrasodium (INS37217 Respiratory) to placebo in 72 patients with CF at 18 clinical centers across the U.S. This second Phase II trial is being conducted in order to gain a greater understanding of safety and tolerability of denufosol in a broader population of CF patients, including patients with lower lung function and patients using antibiotics and other therapeutics, including TOBI (tobramycin) Inhalation Solution.

As stated previously, Inspire plans to initiate a single-center, 15 patient pediatric double-blind, randomized, placebo-controlled Phase II clinical trial of denufosol in five to seven year-old CF patients this summer. This trial, which is expected to be completed prior to initiating Phase III, could enable expansion of enrollment to younger patients in the anticipated Phase III program.

In addition, the dosing phase has been completed for both of Inspire's two six-month inhalation toxicology studies, with final study reports available this fall. These long-term toxicology studies are required by the FDA in order for Inspire to initiate a Phase III program.