UroGen Pharma Submits Investigational New Drug (IND) Application for UGN-102 (VesiGel)

UroGen Pharma (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that it submitted to the U.S. Food and Drug Administration (FDA) an Investigational New Drug (IND) application for UGN-102 (VesiGel, mitomycin gel for intravesical instillation) for the treatment of patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) at the end of Q2 2018. If accepted, the Company expects to begin a Phase 2b clinical trial in the United States in Q3 2018.

As quoted in the press release:

UGN-102 represents the second product candidate in UroGen’s pipeline and addresses an unmet medical need in the treatment of patients with relapsing urothelial cancer of the urinary bladder. The proposed Phase 2b single-arm, open-label, multi-center trial is designed to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with LG NMIBC at risk for recurrence. Transurethral resection of bladder tumor (TURBT) followed by adjuvant chemotherapy or immunotherapy is the current standard of care. In 2012, the annual incidence of urothelial bladder cancer was 80,000 in the United States with a prevalence of 700,000¹. NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year, with the majority of patients experiencing life-long, repetitive surgical treatment for cancer recurrence.

“The IND submission of UGN-102 is a significant milestone for our RTGel™ technology platform. With UGN-102, we have a great opportunity to provide the first non-surgical alternative for patients suffering from chronically relapsing LG NMIBC,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “The positive data observed in the Phase 3 trial of our lead product candidate, UGN-101 (MitoGel^®), is a strong validation of our platform. We are encouraged by the efficacy and durability data generated in a Phase 2a European study of UGN-102 and if our IND is accepted, look forward to beginning the clinical trial in the United States.”

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