Inspire Pharmaceuticals announced results from its first Phase 3 trial with denufosol tetrasodium for the treatment of cystic fibrosis (CF). This trial, TIGER-1, 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 60mg 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, p=0.047). In the open-label extension, patients experienced a progressive improvement in FEV1.
Denufosol is a novel ion channel regulator that potentially corrects ion transport in patients independent of the class of CFTR defect. Denufosol is designed to enhance airway hydration and mucociliary clearance by increasing chloride secretion, inhibiting sodium absorption and increasing ciliary beat frequency.
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