Presented as a late-breaker during the plenary session, the interim results support that in women with OAB, not well managed by oral therapies, a single dose of URO-902 was safe and well tolerated. This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study (NCT04211831). URO-902 was administered via direct intradetrusor injections via cystoscopy under local anesthesia.
'These positive findings indicate that URO-902 has the potential to be a new therapeutic option for overactive bladder patients who have failed oral pharmacologic therapy,' said presenting author
Of the 80 female patients who were randomized, 68 completed week 12 of the study and 74 were included in the intent-to-treat population. The mean age was 64.7 years.
At week 12, both URO-902 24 mg and 48 mg were associated with clinically relevant improvement compared with placebo in mean daily micturition (urination), urgency episodes, UUI episodes, OAB questionnaire symptom bother score, and proportion of patient global impression of change responders. Treatment-emergent adverse events occurred in 45.5% of patients receiving URO-902 24 mg, 46.2% receiving 48 mg, and 50.0% receiving placebo. The most commonly occurring adverse event was urinary tract infection (0% in individuals receiving the 24 mg dose of URO-902; 15.4% in those receiving the 48 mg dose; and 3.8% in those receiving placebo). One patient in the 48 mg arm of the study had asymptomatic elevated post-void residual urine volume at week 2; this resolved spontaneously and did not require catheterization.
'We are encouraged by these promising interim safety and efficacy findings for URO-902,' said
The abstract is available in the
About the Phase 2a Study of URO-902
The 48-week multicenter study was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single physician administered dose of URO-902, a novel gene therapy being developed for patients with OAB who have not been adequately managed with oral or transdermal pharmacologic therapy. URO-902 is administered via direct intradetrusor injections into the bladder wall under local anesthesia in patients who are experiencing OAB symptoms and urge urinary incontinence (UUI).
The Phase 2a trial enrolled 80 female patients in two cohorts: the first cohort received either a single administration of 24 mg of URO-902 or matching placebo, and the second cohort received 48 mg of URO-902 or matching placebo into the bladder wall. Multiple outcome measures were explored, including the effect on the number of micturitions, urgency episodes, and quality-of-life indicators compared to placebo, 12 weeks post-administration, as well as an assessment of the safety and tolerability of this potential new therapy. Patients were followed for up to 48 weeks after initial administration.
About URO-902
URO-902 has the potential to be the first gene therapy for patients with OAB. If approved, this innovative treatment has the potential to address an unmet need for patients who have failed oral pharmacologic therapies.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1
Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient's day-to-day activities.1, 2
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in urology. The Company's lead product, GEMTESA(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the
About Sumitovant Biopharma
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned 'Vant' subsidiaries-Urovant, Enzyvant, Spirovant, Altavant-and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant, a wholly owned subsidiary of
About GEMTESA
GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder: urge urinary incontinence: a strong need to urinate with leaking or wetting accidents; urgency: the need to urinate right away; frequency: urinating often
It is not known if GEMTESA is safe and effective in children.
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