Biotechnology company UroGen Pharma Ltd (Nasdaq: URGN) on Wednesday announced dosing the first patient in the Phase 3 trial of UGN-103, a mitomycin-based formulation for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UGN-103 is an investigational drug, using UroGen's RTGel technology, which offers a shorter manufacturing process and simpler reconstitution. The U.S. Food and Drug Administration (FDA) approved UGN-103's Investigational New Drug Application in April 2024.

The UTOPIA study, enrolling 87 patients, will evaluate UGN-103's efficacy and safety, assessing complete response rates at three months. UroGen anticipates following UGN-103's development with the potential launch of UGN-102, which is currently under FDA review with a decision expected in early 2025.

UroGen received a Notice of Allowance for UGN-103 from the U.S. Patent and Trademark Office on 16 September 2024, with patent expiration set for December 2041. The company's RTGel technology is designed to increase drug exposure to bladder tissue, offering a non-surgical tumor treatment option.

LG-IR-NMIBC represents approximately 22,000 new bladder cancer cases annually in the US, with high recurrence rates requiring repeated treatments. UroGen aims to address this with innovative solutions, advancing the UGN-103 and UGN-102 treatments.