Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

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.

“The significant lung function improvements observed in the subgroup of adolescent patients in the TIGER-1 clinical trial suggest the potential of denufosol as an early disease-stage intervention therapy that may reduce the loss of lung function during this critical time in a CF patient's lung disease progression.”

"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 University School of Medicine and Co-Director of the Children's Health Research Program at Stanford University Medical Center. "The significant lung function improvements observed in the subgroup of adolescent patients in the TIGER-1 clinical trial suggest the potential of denufosol as an early disease-stage intervention therapy that may reduce the loss of lung function during this critical time in a CF patient's lung disease progression."

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 olds 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>1 at the 24-week endpoint was 48 mL for denufosol compared to 3 mL for placebo>1 for adolescent patients receiving placebo from week 0 to week 24 during the TIGER-1 trial was significantly different from zero (p <0.001; corresponding to a decline over the trial period) while the rate of decline in percent predicted FEV1 for adolescent patients receiving denufosol was not significantly different from zero>25%-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.

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. Liou), examines the efficacy of denufosol in patients taking zero to two classes of concomitant medication at baseline for CF lung disease in the TIGER-1 trial>1 scores of approximately 92% predicted normal, comparable to the ITT population in the trial. In this post-hoc analysis, denufosol demonstrated benefit compared to placebo in pulmonary function tests and quality of life respiratory score in those patients with minimal pharmacotherapy. For the week-24 endpoint of FEV1 in liters, the treatment effect in the subgroup was 100 mL>1 was 6.4%.

Inspire is presenting a poster presentation entitled, "Aerosol and Pharmacokinetic Properties of Denufosol Support its Use for Early Intervention in CF Lung Disease" (T. Navratil, A. Schaberg, F. Johnson, T. Durham, C.L. Ren, F. Ratjen, R.B. Moss. F.J. Accurso), which summarizes in vitro data that suggest that denufosol, as a result of its aerosol and chemical characteristics, has the potential to reach the small airways of the lungs, where CF lung disease begins. This was supported by a post-hoc analysis of the TIGER-1 trial data, which showed a significant improvement relative to placebo in FEF25%-75% in a subgroup of patients>1 ≤110% predicted normal.

Inspire is presenting a poster presentation entitled, "Analysis of Polypharmacy in Patients with Mild Cystic Fibrosis Lung Disease Assigned to Placebo in Phase 3 Clinical Trial of Denufosol" (T. Durham, T. Navratil, A. Schaberg, C. Deans, L. Smiley, N. Herje, F. J. Accurso). As an assessment of the magnitude of concomitant medication use independent of treatment effects with denufosol, a post-hoc analysis of patients assigned to placebo during the TIGER-1 clinical trial>1 ≥90% predicted) as it was in those with lower lung function (FEV1 ≥75% to <90% predicted). The development of disease modifying therapies that address the underlying cause of CF lung disease may reduce the need for extensive polypharmacy.

These presentations will be available on Inspire's website, www.inspirepharm.com, following the conference.

Source Inspire

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