Tiger-1 is a double-blind, placebo-controlled, randomized study comparing 60mg of Denufosol to placebo, administered three times daily by jet nebulizer, in approximately 350 patients with mild cystic fibrosis (CF) lung disease. The approximate mean age of patients enrolled in tiger-1 is 14 years.
The trial includes a 24-week efficacy and safety portion, followed by a 24-week open-label Denufosol safety extension. Of the patients who have completed the efficacy portion to date, approximately 98% are currently enrolled in the safety extension. The primary efficacy endpoint is change from baseline in FEV1 (forced expiratory volume in one second) in liters at the 24-week time point.
Inspire also announced the anticipated timing of tiger-2, the second Phase III clinical trial with Denufosol. Inspire will work initially with select CF treatment centers in the US and Canada for the remainder of 2007 to prepare for patient enrollment.
Christy Shaffer, president and CEO of Inspire, said: “We are very excited to have reached this milestone in the Phase III development of Denufosol, a novel compound that has the potential to treat the underlying cause of CF.”