UroGen Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Core Insights - UroGen Pharma Ltd. has completed patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103, a next-generation formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][3] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary technologies like RTGel for sustained drug release [8] - The company aims to provide non-surgical treatment options for bladder cancer patients, with UGN-103 representing a significant advancement in its pipeline [3][5] Clinical Trial Details - The UTOPIA trial enrolled 99 patients globally and is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 [2][3] - Patients receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks, with the primary endpoint being the complete response rate at three months [3] Product Information - UGN-103 is designed to improve upon ZUSDURI (mitomycin) by offering a shorter manufacturing process and simplified reconstitution [2][5] - UroGen has received a Notice of Allowance for patent protection of UGN-103, expected to last until December 2041 [4] Market Context - LG-IR-NMIBC affects approximately 82,000 people annually in the U.S., with around 59,000 cases being recurrent [7] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients experience at least one recurrence [7]