Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder
- Vibegron met both co-primary endpoints demonstrating highly significant reduction in daily urge urinary incontinence episodes and micturitions, compared to placebo (p<0.0001 and p<0.001, respectively)
- Vibegron met all seven key secondary endpoints, including a clinically meaningful reduction in daily urgency episodes versus placebo (p=0.002)
- Vibegron achieved rapid onset at two weeks in both co-primary endpoints and daily urgency episodes (p<0.001 for these endpoints) and statistically significant efficacy was maintained at all timepoints measured through the end of the study
- Vibegron could potentially be the first new prescription drug in nearly a decade for the millions of patients suffering from overactive bladder (OAB)
- Urovant to host investor conference call March 19, 2019
In the primary efficacy analysis, once-daily vibegron met the co-primary endpoints at week 12, achieving statistical significance over placebo on both reduction in daily urge urinary incontinence (UUI) episodes (p<0.0001) and reduction in daily micturitions (p<0.001). The difference from placebo was statistically significant as early as week 2, which was the first timepoint measured, for both UUI episodes and micturitions (p<0.0001 and p<0.001, respectively), and statistically significant efficacy was maintained at all timepoints measured through the end of the study for both endpoints. Additionally, at all measured timepoints, vibegron achieved numerically better efficacy than tolterodine, the active control in this study, which is a currently available OAB treatment.
All seven pre-specified key secondary endpoints were met, including a statistically significant reduction in daily urgency episodes compared to placebo (p=0.002). Other endpoints that were not part of the topline data analysis will be presented at future medical meetings.
Vibegron was well tolerated and the most common adverse events reported versus placebo (>2% in vibegron and greater than placebo) were headache (4.0% vs 2.4%), nasopharyngitis (2.8% vs 1.7%), diarrhea (2.2% vs 1.1%), and nausea (2.2% vs 1.1%). The frequency of serious adverse events was similar across treatment arms (1.1% in placebo, 1.5% in vibegron, and 2.3% in tolterodine). The incidence of the reported adverse event of hypertension was equal to placebo (1.7% in vibegron, 1.7% in placebo, and 2.6% in tolterodine). Full vital sign data, including blood pressure, were not part of the topline data analysis.
Based on these topline results, Urovant intends to file a New Drug Application (NDA) with the
“There is a significant need for innovative new treatment options for OAB patients, as many patients are unable to find relief with currently available medicines,” said Dr.
“We believe these efficacy and safety results represent a significant advancement in the treatment of OAB, positioning vibegron as a potential best in class therapy,” said
EMPOWUR is an international randomized, double-blind placebo- and active comparator controlled clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. A total of 1,518 patients were randomized across 215 study sites into one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine ER 4 mg administered orally once daily. Additionally, 507 patients who completed the EMPOWUR trial were enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment. The co-primary endpoints of the EMPOWUR study are: change from baseline in the average number of micturitions per 24 hours; and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have an average of one or more UUI episodes per day prior to treatment. Secondary endpoints included changes in the frequency of urinary urgency episodes and incontinence episodes, and self-reported quality of life scores.
Urovant will host a conference call today
A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406. The conference ID is 9455883. A webcast will be archived on the Investor Relations page of the
About Overactive Bladder
Overactive bladder is a clinical condition characterized by the sudden urge to urinate that is difficult to control (urgency), with or without accidental urinary leakage (urge urinary incontinence), and usually with increased frequency of urination. The exact cause is unknown, making this a difficult condition to treat. In the
About Roivant Sciences
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com
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