Inspire shares rocket on good CF drug results

North Carolina, USA-based Inspire Pharmaceuticals says top-line results from the 352-patient, double-blind, 24-week placebo-controlled portion of its Phase III trial (TIGER-1) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis are positive. The news sent the firm's share price leaping 35% to $5.19 on June 6.

The trial demonstrated statistical significance for its primary efficacy endpoint, which was the change in Forced Expiratory Volume in One Second (FEV1) from baseline at the trial endpoint (at 24 weeks or last observation carried forward). Patients treated with denufosol had a statistically-significant improvement in FEV1 compared to placebo (45 milliliter treatment group difference, p=0.047). On average, subjects on denufosol improved relative to baseline whereas those on placebo remained essentially unchanged. The treatment effect of denufosol increased over the 24-week placebo-controlled period, and available preliminary data from around 210 patients who have completed the ongoing open-label safety extension (including the placebo patients switched to denufosol) suggest that FEV1 continued to improve during the extension period from weeks 24 to 48.