Inspire Pharmaceuticals Inc, Durham, NC, will present data today from its TIGER-1 first phase 3 clinical trial with denufosol at the [removed]24th annual North American Cystic Fibrosis Conference[/removed] in Baltimore.
Trial results show that denufosol, a novel inhaled ion-channel regulator, has potential to benefit adolescent patients and those on minimal concomitant therapies. The company’s research also suggests that denufosol inhibits sodium absorption, stimulates chloride secretion, and has the potential to target the small airways of the lungs where CF lung disease begins.
Patients in the TIGER-1 trial who were taking zero to two classes of concomitant medications for CF lung disease at baseline (n=71, intent-to-treat, or ITT=352) had a baseline percent predicted FEV1 of 93% in the denufosol group and 91% in the placebo group. During double-blind treatment, FEV1 improved with denufosol over placebo by 5.7% (p=0.028) or 100 mL (p=0.059) with a net improvement of 6.4% over placebo in percent predicted FEV1 (p=0.011). Patients on 48 weeks of denufosol improved versus baseline by 12% or 193 mL for FEV1 and 2.2% for percent predicted FEV1. These improvements exceeded those in the ITT population in which >50% of patients used ≥4 pharmacotherapies.
The study found that denufosol was well tolerated with a safety profile comparable to that of placebo.
Source: Inspire Pharmaceuticals Inc