DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that it has completed patient enrollment in TIGER-1, the first of two planned pivotal Phase 3 clinical trials with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF). The Company expects top-line efficacy data from TIGER-1 to be available mid-year 2008, which is earlier than previously projected. TIGER-1, initiated in July 2006, is a double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in approximately 350 patients with mild CF lung disease. The approximate mean age of patients enrolled in TIGER-1 is 14 years. The trial includes a 24-week efficacy and safety portion, followed by a 24-week open-label denufosol safety extension. Of the patients who have completed the efficacy portion to date, approximately 98% are currently enrolled in the safety extension. The primary efficacy endpoint is change from baseline in FEV1 (forced expiratory volume in one second) in liters at the 24-week time point.
