Stage (next event)
Phase 2a (DSMB Meeting)
December 2020 / Early 2021
Catalyst Info & Data Links
TITLE: URO-902 in Overactive Bladder (OAB) - Phase 2a DSMB Meeting
ClinicalTrial.gov (NCT04211831): URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
WHAT IS THE NEXT CATALYST EVENT?
Phase 2a DSMB Meeting
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
December 2020 / Early 2021 (see slide 6)
2020: September Corporate Update (see slide 6)
2020: Evaluating the safety and potential activity of URO‐902 (hMaxi‐K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non‐neurogenic) overactive bladder syndrome and detrusor overactivity from two double‐blind, imbalanced, placebo‐controlled randomized phase 1 trials. Neurourology and urodynamics, 39(2), 744-753.
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
Urovant’s second investigational product candidate, URO-902 , is a novel gene therapy for patients with overactive bladder (OAB) symptoms who have failed oral pharmacologic therapy. URO-902 has been evaluated in two Phase 1 studies in OAB patients including a small, double-blind, placebo-controlled Phase 1b clinical trial as an intravesical injection in women with overactive bladder symptoms. Ion Channel Innovations completed the Phase 1b study in 2017 and found URO-902 to be generally well tolerated. Efficacy results of the trial, which included a limited number of patients (n=13), indicated dose-dependent improvements in urinary urgency and frequency, achieving statistical significance (p<0.05) in the high dose cohort. Urovant expects to initiate a Phase 2 URO-902 study in 2019 (Learn more HERE).
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