Inspire reports positive results from Phase III cystic fibrosis trial

The new data indicate that patients who continued to receive denufosol for an additional 24 weeks during the open-label extension experienced a progressive improvement in forced expiratory volume in one second (FEV)(1). These patients who received denufosol for 48 weeks during Tiger-1 experienced a mean change from baseline in FEV(1 )of 115ml, almost a two-and-a-half fold increase compared to the initial 48ml increase at the end of the 24-week placebo-controlled portion of the trial.

The patients who crossed over from placebo to denufosol at week 24 also experienced improvements in FEV(1) when receiving denufosol during the open-label extension. These patients had a 78ml increase from baseline, of which only 3ml were observed during the 24-week placebo-controlled portion of the trial.

The patient retention rate in the open-label extension was high, with an approximate 95% completion rate for the patients who entered the open-label extension. The detailed results from the open-label extension of Tiger-1 are expected to be available in the first quarter of 2009.

Frank Accurso, principal investigator of Tiger-1, said: “These are very exciting, promising data suggesting that denufosol can make a difference for cystic fibrosis patients, particularly since the therapy could benefit all types of patients regardless of their specific genetic mutation.

“The clinically-meaningful improvement in FEV(1) that continues over time without apparent abatement at week 48 is particularly notable in patients with relatively mild lung function impairment.”