Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.
“These exciting data suggest that denufosol may have promise in this mild patient population. The improvement in lung function observed during the placebo-controlled portion and the open-label extension of the TIGER-1 trial is notable given that the patient population studied had little to no pulmonary function impairment.”
The article entitled, "Denufosol Tetrasodium in Patients with Cystic Fibrosis and Normal to Mildly Impaired Lung Function" (Frank J. Accurso, M.D.; Richard B. Moss, M.D.; Robert W. Wilmott, M.D.; Ran D. Anbar, M.D.; Amy E. Schaberg, BSN, RN; Todd A. Durham, M.S.; Bonnie W. Ramsey, M.D.; and the TIGER-1 Investigator Study Group), appeared today online ahead of the print edition (http://ajrccm.atsjournals.org/).
Frank J. Accurso, M.D., Head of Pulmonary Medicine, Director of Cystic Fibrosis Center at University of Colorado, Denver, and the lead principal investigator for TIGER-1 stated, "These exciting data suggest that denufosol may have promise in this mild patient population. The improvement in lung function observed during the placebo-controlled portion and the open-label extension of the TIGER-1 trial is notable given that the patient population studied had little to no pulmonary function impairment."
The TIGER-1 trial included a 24-week placebo-controlled portion, followed by a 24-week open-label safety extension. The placebo-controlled portion was a double-blind, randomized trial comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in 352 patients with mild CF lung disease (baseline FEV1, or Forced Expiratory Volume in One Second, ≥75% of predicted normal). The TIGER-1 trial demonstrated statistical significance for its primary efficacy endpoint of change in FEV1 from baseline compared to placebo at the Week 24 Endpoint (45 mL treatment group difference,>1/sub>. Detailed analyses from the trial are included in the AJRCCM publication.
Adrian Adams, President and CEO of Inspire stated, "We believe this publication represents valuable information for the CF medical community because it puts the data from TIGER-1, the first large Phase 3 trial of an ion channel regulator, into context in the current treatment landscape. The results from our second Phase 3 trial with denufosol, TIGER-2, are expected in the first quarter of 2011, which will provide further information."
Inspire Pharmaceuticals, Inc.