UroGen Announces Start of Pivotal Single-Arm Phase 3 Trial for UGN-102, an Investigational Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

— ENVISION Study Design Similar to Successful UGN-102 Phase 2b OPTIMA II Trial —

Excerpt from the Press Release:

PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).

ENVISION is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The study design is similar to the Phase 2b OPTIMA II study in that patients will have the same clinical characteristics, treatment regimen, assessment, and qualitative follow up but with different endpoints. ENVISION is expected to enroll approximately 220 patients across 90 sites. Based on discussions with the U.S. Food and Drug Administration (FDA), and enrollment expected by end of 2022, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.

“The start of the ENVISION trial marks the final phase of validating primary chemoablation for the treatment of recurrent intermediate risk NMIBC,” said Sandip Prasad, Urologist, Atlantic Health System, Morristown Medical Center, NJ, and lead study investigator for the ENVISION trial. “This study is designed to support the clinical potential of UGN-102 as a new treatment for patients that are under-served by the current standard of care, including those patients at risk for recurrence and those that are unwilling or unable to endure surgery or anesthesia.”

For the new Phase 3 trial, study participants will receive 6 once-weekly intravesical instillations of UGN-102. The planned primary endpoint is the complete response rate at three months after the first instillation, and the key secondary endpoint will be durability over time in patients who achieve complete response at the three-month assessment.

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