UroGen Pharma announces results from Phase 1 study of UGN-301

UroGen Pharma (URGN) announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer, NMIBC. The multi-part clinical study included up to 30 patients per arm, aimed to assess safety and determine the recommended Phase 2 dose of UGN-301 as monotherapy and in combination with other agents. With respect to clinical activity observed in the trial, among evaluable patients who received UGN-301, 46% of those with Ta/T1 disease and 33% of those with carcinoma in situ, CIS, +/- Ta/T1 disease were recurrence-free or had achieved a complete response at week 12. Notably, 60% of patients with Ta/T1 disease treated with 300 mg continued to remain recurrence-free at the 15-month disease assessment, including one patient with high-grade T1 disease. In the 500 mg cohort, 25% of patients with CIS disease and 33% of patients with Ta/T1 disease remained disease-free at six months, both of whom are still active participants in the study.