Phase III LEADERSHIP 301 trial of AQX 1125 fails to reach primary endpoint in interstitial cystitis/bladder pain syndrome.- Aquinox Pharma.

Aquinox Pharmaceuticals announced that the Phase III LEADERSHIP 301 clinical trial evaluating once-daily, oral AQX 1125 (rosiptor) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint. LEADERSHIP 301 enrolled 433 participants, including 341 female subjects who were randomized to receive rosiptor 100 mg or 200 mg, or placebo. The trial was balanced in terms of baseline characteristics between arms, and enrolled a population very similar to the prior Phase II trial.

Rosiptor failed to achieve a statistically significant reduction in the mean change from Baseline at Week 12 in maximum daily bladder pain score compared to placebo (P=0.41) in the female subjects, which was the primary endpoint. Rosiptor was generally well tolerated with the rate of adverse events during the 12-week treatment period similar to that of placebo and prior trials.

Comment: The LEADERSHIP 301 trial was a three-arm, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial assessing the effect of once-daily rosiptor (AQX-1125) on bladder pain and urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS). Subjects were enrolled at leading clinical research centers in the United States, Canada, and Europe.