The trial aims to enrol 87 subjects with low-grade intermediate-risk non-muscle invasive bladder cancer. Credit: Antonio Marca/Shutterstock.

UroGen Pharma has announced the dosing of the first subject in the Phase III UTOPIA clinical trial of its investigational drug UGN-103 (mitomycin) for an intravesical solution to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The trial aims to enrol 87 subjects and will assess the efficacy and safety of the potential treatment.

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In the single-arm, multicentre trial, each participant will receive a 75mg dose of UGN-103 through intravesical instillation once a week for six weeks.

The drug’s efficacy will be assessed based on the complete response rate at the three-month visit post-treatment.

Patients who achieve a complete response, defined as having no detectable disease in the bladder at the three-month visit, will proceed to the follow-up period of the trial.

These patients will be evaluated every three months to monitor their response. They will continue in the study until the occurrence of disease recurrence, progression, death, or until the last patient completes 12 months of follow-up.

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UGN-103 is a new formulation of mitomycin that utilises UroGen’s RTGel platform technology.

This reverse-thermal hydrogel technology aims to enhance the therapeutic profiles of existing therapies by providing sustained release.

The US Food and Drug Administration (FDA) accepted the investigational new drug application for UGN-103 in April this year, allowing for the investigational use of the drug in adults with LG-IR-NMIBC.

UroGen Pharma president and CEO Liz Barrett said: “Reaching this Phase III trial milestone for UGN-103 highlights our drive to innovate and bring forward cutting-edge treatments for low-grade intermediate-risk non-muscle invasive bladder cancer.

“UGN-103 represents a significant step forward, offering potential improvements in manufacturing, convenience, and cost. We are excited about the potential of this next-generation formulation and look forward to furthering its development to advance the care of patients.”

In December 2022, the company reported findings from the Phase IIb OPTIMA II trial of UGN-102 (mitomycin) to treat LG-IR-NMIBC.