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news.Urigen Pharmaceuticals has announced the early closure of the URG101-104 study due to positive, statistically significant interim analysis results in both the primary and all secondary endpoints.
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The URG101-104 study was a pharmacodynamic and safety study investigating the treatment of painful bladder syndrome or interstitial cystitis (PBS/IC). The cross-over design utilized provided sufficient power to reliably assess treatment effects using modestly sized study cohorts. This study in combination with previous studies has treated a total of 200 subjects to date and further demonstrated that URG101 is safe and well-tolerated.
Dennis Giesing, Urigen’s chief scientific officer, said: “Based upon further review, it has been determined continuing enrollment will not meaningfully alter the study conclusions. This decision allows us to now accelerate the full development of URG101.”