Jun. 17, 2010 (Business Wire) -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain. The data from Inspire’s first Phase 3 clinical trial with denufosol, TIGER-1, suggest that denufosol, an inhaled ion channel regulator, may ameliorate the accelerated loss of lung function in CF patients during adolescence and has the potential to provide significant benefit in lung function for those patients on minimal pharmacotherapies.
“During adolescence, CF patients are especially vulnerable to an accelerated rate of decline in lung function and there is a consequent need for therapies that delay or reduce lung function loss in this population,” stated Richard B. Moss, M.D., Professor Emeritus of Pediatric Pulmonary Medicine at Stanford
The oral presentation, “Denufosol Improved Lung Function in Adolescent CF Patients” (R.B. Moss, A. Schaberg, C. Deans, W. Tian, L. Smiley, N. Herje, T. Durham, F.J. Accurso), is being presented during the session, “Workshop 5: Current Clinical Trials,” on Thursday, June 17 from 3:30 - 3:45 p.m. local time (9:30 - 9:45 a.m. ET). The presentation highlights subgroup data from the pre-specified analysis of adolescent CF patients aged 12-18 years old (n=123) from Inspire’s first Phase 3 clinical trial with denufosol, TIGER-1. In this trial, denufosol significantly improved lung function versus placebo in adolescents during the 24-week double-blind portion of TIGER-1 and continued improvement in lung function was observed with open-label treatment. The change from baseline in FEV1 (Forced Expiratory Volume in One Second) for the adolescent patients treated with denufosol at the week-24 endpoint was 112 mL compared to -10 mL for placebo (p=0.013). In comparison, in the intent-to-treat (ITT) population in TIGER-1 (n=352), the change from baseline in FEV1 at the 24-week endpoint was 48 mL for denufosol compared to 3 mL for placebo (p=0.047). The rate of decline in percent predicted FEV1 for adolescent patients receiving placebo from week 0 to week 24 during the TIGER-1 trial was significantly different from zero (p <0.001;>1 for adolescent patients receiving denufosol was not significantly different from zero (p=0.134). The change from baseline for FEF25%-75% (Forced Expiratory Flow), a measure of small airways function, for the adolescent patients treated with denufosol at the week-24 endpoint was 115 mL/sec. compared to -112 mL/sec. for placebo (p=0.036).
The Company is also presenting three additional posters at the ECFS Conference. The poster presentation, “Potential of Denufosol as an Early Intervention in CF Lung Disease: Efficacy in Patients with Minimal Pharmacotherapy in a U.S. Phase 3 Clinical Trial” (F.J. Accurso, W. Tian, A. Schaberg, T. Navratil, M.S. Howenstine, T.G.