UroGen Pharma has completed the enrolment of subjects in its Phase III UTOPIA trial, which is evaluating UGN-103 (mitomycin) for intravesical solution, being developed to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The multicentre, single-arm trial has enrolled 99 subjects from various centres globally to assess the efficacy and safety of the therapy, which leverages the company’s RTGel technology that facilitates prolonged bladder exposure and sustained drug release.
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Trial subjects will be given 75 mg of UGN-103 through intravesical instillation once a week for a six-week period.
Complete response rate at three months is the primary goal of the trial, and those who respond to the treatment will enter a follow-up phase lasting up to 12 months to evaluate the durability of the response.
UGN-103 is being developed as a next-generation formulation that offers potential improvements over Zusduri (mitomycin) for intravesical solution.
Zusduri, which also uses the RTGel technology, is approved for treating adults with recurrent LG-IR-NMIBC.
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By GlobalDataUroGen Pharma Medical Affairs and Clinical Development executive vice-president Michael Louie said: “Completing enrolment 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.
“UGN-103 represents a pivotal advancement in our pipeline, aiming to deliver the same non-surgical benefits to patients as Zusduri, while also enhancing operational efficiency and convenience for providers.”
In September last year, the company obtained a Notice of Allowance from the US Patent and Trademark Office for the use of UGN-103 in treating LG-IR-NMIBC, with patent protection anticipated to extend until December 2041.
In January the same year, the company signed a licensing and supply deal with medac for the therapy development covering the same indication.
In 2024, the company reported the results from a long-term follow-up trial of Jelmyto (mitomycin) for pyelocalyceal solution to treat low-grade, upper tract urothelial cancer (LG-UTUC) in adults.
