Urovant Sciences to Announce Topline Results from the EMPOWUR Phase 3 Study of Vibegron in Patients with Overactive Bladder

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The conference call numbers are (866) 470-1049 for domestic callers and +1 (409) 217-8245 for international callers.

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Provider: 
Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Monday, March 18, 2019
Information
Tags: 
Health, Biotechnology, Clinical trials, Pharmaceutical, Roivant Sciences, Urology
Geotags: 
United States, Europe, California, SWITZERLAND
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Summary
Key Points: 
  • The conference call numbers are (866) 470-1049 for domestic callers and +1 (409) 217-8245 for international callers.
  • 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.
  • Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, is a subsidiary of Roivant Sciences.
  • Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron.


Urovant Sciences (Nasdaq: UROV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for urologic conditions, today announced it will
host a conference call and live webcast to discuss topline results from
the EMPOWUR international pivotal phase 3 study on Tuesday, March 19,
2019 at 8:30 a.m. ET. A question and answer session will follow
management’s remarks.

The conference call numbers are (866) 470-1049 for domestic callers and
+1 (409) 217-8245 for international callers. The conference ID is
9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.

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 for international callers. The conference
ID is 9455883. A webcast will be archived on the Investor Relations page
of the Urovant Sciences website immediately after the call and available
for at least 30 days.

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 United States, more than 30
million people over the age of 40 suffer from the bothersome symptoms of
OAB1, which can lead to depression, anxiety and a negative
impact on quality of life.2

About EMPOWUR

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 in all
patients; and change from baseline in the average number of urge urinary
incontinence (UUI) episodes per 24 hours in patients who have 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.

About Urovant Sciences

Urovant Sciences, a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for urologic
conditions, is a subsidiary of Roivant Sciences. Urovant leverages the
Roivant platform to develop therapies that address high unmet medical
needs while driving greater efficiency in research, clinical
development, and commercialization. Urovant’s lead product candidate,
vibegron, is an oral, once-daily, small molecule beta-3 adrenergic
agonist being evaluated for the treatment of OAB with symptoms of urge
urinary incontinence, urgency, and urinary frequency; for OAB in men
with benign prostatic hyperplasia; and for abdominal pain associated
with irritable bowel syndrome. Urovant has licensed global rights,
excluding Japan and certain Asian territories, for the development and
commercialization of vibegron. Urovant’s second product candidate,
URO-902, is a novel gene therapy being developed for patients with OAB
who have failed oral pharmacological therapy. Urovant intends to develop
treatments for additional urologic diseases. For more information,
please visit www.urovant.com.

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.

1. Coyne, et al., EpiLUTS 2007
2. Kinsey
D, et al., J Health Psychol. 2016

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