Company halts study of IC drug due to positive results

Urigen Pharmaceuticals has announced the early closure of its study of a drug known as URG101 due to positive, statistically significant interim analysis results in both the primary and all secondary endpoints. Top-line results of the interim analysis, which was planned at 50% enrollment, were previously released March 12.

The URG101-104 study was a pharmacodynamic and safety study investigating the treatment of painful bladder syndrome/interstitial cystitis. According to the manufacturer, the study design provided sufficient power to reliably assess treatment effects across modestly sized cohorts; thus, continuing enrollment would not meaningfully alter the study conclusions of safety and tolerability. Accelerated development of the drug is anticipated.