Inspire Scores on Cystic Fibrosis Phase III (ISPH)
Inspire Pharmaceuticals Inc. (NASDAQ: ISPH) is seeing shares surge in pre-market trading this Friday morning. The company announced that it reached its primary endpoint in Phase III trial of Denufosol for Cystic Fibrosis.
This is regarding its top-line results from a 352-patient, double-blind, 24-week placebo-controlled portion of its Phase III trial with Denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis. Denufosol demonstrated statistical significance for the change in FEV1 from baseline at the trial endpoint, its primary endpoint. There was a statistically significant improvement in FEV1 compared to the placebo.
Patients on denufosol improved relative to baseline whereas patients on placebo remained essentially unchanged; while the treatment effect of denufosol increased over the 24-week placebo controlled period. Preliminary data from 210 patients who have completed the ongoing open-label safety extension suggest that FEV1 continued to improve during the extension period from weeks 24 to 48.
Shares closed at $3.85 yesterday, and shares are now up at $6.40 in pre-market trading with just under an hour to go. Before the pop, this was a $217 million market cap.
Jon C. Ogg
June 6, 2008