UroGen Completes Patient Enrollment in Phase 3 UTOPIA Clinical Trial

UroGen Pharma has completed patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103 (mitomycin) for intravesical solution, a treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The trial enrolled 99 patients globally and aims to improve upon ZUSDURI with a shorter manufacturing process and simplified reconstitution procedure. UGN-103 uses UroGen's proprietary sustained release RTGel technology for sustained drug release and prolonged bladder exposure.

Title: UroGen Pharma Completes Enrollment in Phase 3 UTOPIA Trial for UGN-103

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing innovative solutions for urothelial and specialty cancers, has completed patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103 (mitomycin) for intravesical solution. The trial, which enrolled 99 patients across multiple centers globally, aims to evaluate the efficacy and safety of UGN-103 in treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1].

UGN-103 utilizes UroGen's proprietary sustained release RTGel® technology, which enables sustained drug release and prolonged bladder exposure. This next-generation formulation is designed to offer improvements over ZUSDURI™ (mitomycin) for intravesical solution, including a shorter manufacturing process and simplified reconstitution procedure [1].

The UTOPIA trial is a single-arm, multicenter study that will evaluate the efficacy and safety of UGN-103. All enrolled patients will receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks. The primary endpoint is the complete response rate at three months, with responders entering a follow-up phase of up to 12 months to assess the durability of response [1].

The completion of enrollment in the UTOPIA trial marks a significant milestone for UroGen, as it aims to advance UGN-103 as a next-generation treatment option for patients with recurrent LG-IR-NMIBC. Michael Louie, M.D., EVP, Medical Affairs and Clinical Development at UroGen, stated, "Completing enrollment in the UTOPIA trial marks a significant milestone in our efforts to advance UGN-103 as a next-generation treatment option for patients with recurrent LG-IR-NMIBC" [1].

In addition to the clinical trial, UroGen has secured patent protection for UGN-103 through December 2041 following a Notice of Allowance from the U.S. Patent and Trademark Office in September 2024. This patent protection covers the use of UGN-103 for LG-IR-NMIBC [1].

The UTOPIA trial is a critical step in UroGen's pipeline, aiming to deliver the same non-surgical benefits to patients as ZUSDURI, while also enhancing operational efficiency and convenience for providers. The successful completion of enrollment in the UTOPIA trial suggests that UroGen is making significant progress in its efforts to develop innovative treatments for bladder cancer [1].

References:
[1] https://investors.urogen.com/news-releases/news-release-details/urogen-announces-completion-enrollment-phase-3-utopia-clinical