Urovant Sciences Initiates Phase 3 Clinical Program for Vibegron in Patients with Overactive Bladder

  • Pivotal trial will enroll approximately 1,400 patients for 12-week treatment period
  • Program supported by prior dosing in 2,350 subjects and positive Phase 2b and Phase 3 results

BASEL, Switzerland and IRVINE, Calif., March 28, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that it has initiated an international Phase 3 trial, EMPOWUR, to evaluate the safety and efficacy of vibegron, an investigational oral β3-adrenergic agonist, in adults with symptoms of overactive bladder.

“I am proud of our team’s efforts to rapidly launch this pivotal study for a promising therapy,” said Keith Katkin, Chief Executive Officer of Urovant. “Overactive bladder affects millions of individuals and patients need better alternatives to the current standard of care.”

Vibegron has been previously evaluated in 16 Phase 1 studies, one large international Phase 2b dose-ranging study in patients with overactive bladder, and a successful Phase 3 program in Japanese patients with overactive bladder.

About the Phase 3 Trial

The EMPOWUR study is a randomized, double-blind, placebo- and active comparator-controlled international Phase 3 clinical trial in men and women with symptoms of overactive bladder. The study is expected to enroll approximately 1,400 patients.

Individuals who meet eligibility requirements will be randomized to one of three groups for a 12-week treatment period: vibegron 75 mg administered orally once daily, placebo administered orally once daily, or tolterodine ER 4 mg administered orally once daily. Eligible patients completing the initial 12-week blinded assessment will be offered the opportunity to enroll in a 40-week double-blind extension study to evaluate the safety of longer-term treatment.

The co-primary efficacy endpoints of the study are:

  • Change from baseline in the average number of micturitions per 24 hours in all patients
  • Change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients with an average of ≥ 1 UUI episodes per day prior to treatment

Secondary endpoints will include changes in the frequency of incontinence episodes and urinary urgency episodes, and self-reported quality of life scores. Adverse events will be monitored during both the trial and the extension study.

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron and over 2,350 individuals have received vibegron in past studies.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Related Links

http://www.urovant.com

Urovant Sciences Announces Upcoming Presentations of Data from Phase 2b Trial of Vibegron in Patients with Overactive Bladder

  • Urovant Sciences, today announced that clinical data from a Phase 2b study of vibegron will be presented at two upcoming medical congresses.
  • Eight-week results from the vibegron dose-ranging trial will be presented at the 2018 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)

BASEL, Switzerland and IRVINE, Calif., February 28, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that clinical data from a Phase 2b study of vibegron will be presented at two upcoming medical congresses.

Eight-week results from the vibegron dose-ranging trial will be presented at the 2018 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), which is being held February 27-March 3 in Austin, Texas. In addition, 52-week data from an extension of the same vibegron trial will be presented at the 113th Annual Meeting of the American Urological Association (AUA), which is being held May 18-21 in San Francisco, California.

Details for both presentations are as follows:

SUFU Oral Presentation

  • Date and Time: March 3, 2018 at 8:10 a.m. CT
  • Abstract (#34): Vibegron, a Novel Once Daily Oral β-3 Agonist, Significantly Reduces Average Daily Micturitions, Urge Incontinence Episodes and Urgency Episodes in Patients with Overactive Bladder
  • Location: Austin, Texas
  • Presenter: David Mitcheson

AUA Oral Presentation

  • Date and Time: May 20, 2018 at 3:30 p.m. PT
  • Abstract (#18-2878): Durable Efficacy and Safety of Long-Term Once-Daily Vibegron, A Novel Oral β-3 Adrenergic Receptor Agonist: A 52-Week Phase 2 Study in Patients with Overactive Bladder Symptoms
  • Location: San Francisco, California
  • Presenter: Roger Dmochowski

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Urovant Sciences Appoints Keith A. Katkin as CEO

  • Former CEO of Avanir Pharmaceuticals joins Roivant family of companies
  • Plans to initiate confirmatory Phase 3 program of vibegron by early 2018

BASEL, Switzerland, September 18, 2017 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced the appointment of Keith A. Katkin as Chief Executive Officer.

“I am excited to build Urovant into a leading company in the field of urology,” said Mr. Katkin. “Vibegron is a promising drug with strong Phase 2 and Phase 3 data. I look forward to rapidly advancing the development of vibegron including the initiation of a confirmatory Phase 3 pivotal trial in the months to come.”

“I’d like to extend a warm welcome to Keith,” said Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant Sciences. “His track record of building successful companies and his passion for delivering new medicines to patients makes me excited to see him take charge as the leader of one of our newest Vants.”

Mr. Katkin recently served as President and Chief Executive Officer of Avanir Pharmaceuticals from 2007 to 2016, where he oversaw the company’s sale to Otsuka Pharmaceutical Co., Ltd. Mr. Katkin joined Avanir in 2005 as Senior Vice President of Sales and Marketing and was responsible for developing and executing the corporate strategy that led to the approval and commercialization of NUEDEXTA.

Prior to Avanir, Mr. Katkin served as Vice President, Commercial Development for Peninsula Pharmaceuticals, Inc. where he played a key role in the concurrent initial public offering and sale of the company to Johnson and Johnson. Earlier in his career, Mr. Katkin held leadership roles at InterMune, Amgen, and Abbott Laboratories. Mr. Katkin earned his B.S. in Business and Accounting from Indiana University and his M.B.A. from the Anderson School at UCLA. He is a licensed Certified Public Accountant.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron (formerly MK-4618) from Merck. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

We advance our drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also plans to launch new companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit roivant.com.

Related Links

http://www.urovant.com

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