Urovant Sciences Announces Publication of Phase 2b Data for Vibegron in European Urology

 

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 1, 2018– Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced the publication of positive results from the international Phase 2b study of vibegron, an investigational oral beta-3 adrenergic agonist being studied for adults with symptoms of overactive bladder (OAB).

The study, which demonstrated once-daily vibegron was well-tolerated and improved OAB symptoms, was published online by European Urology, a peer-reviewed medical journal and official journal of the European Association of Urology.

The international, randomized double-blind, placebo-controlled Phase 2b study including an active comparator enrolled more than 1,300 patients with OAB symptoms including frequent urination, sudden urge to urinate, and urge incontinence (leakage). In the two-part trial, patients were first randomized to once-daily oral vibegron monotherapy (3 mg, 15 mg, 50 mg or 100 mg); tolterodine extended release (4 mg); or placebo for eight weeks. In part two, patients were randomized to monotherapy, combination therapy or placebo and received either vibegron (100 mg); tolterodine (4 mg); combination vibegron (100 mg) and tolterodine (4 mg); or placebo for four weeks.

In part one, patients randomized to vibegron 50 mg and 100 mg had clinically and statistically significant decreases in the daily number of micturitions, urgency urinary incontinence episodes, total incontinence episodes and urgency episodes at week 8, versus placebo. Moreover, as early as week 2, treatment with both vibegron 50 mg and vibegron 100 mg was associated with statistically significant decreases compared to placebo across all of these key overactive bladder endpoints. Vibegron was generally well-tolerated and there were no meaningful differences in incidence or severity of adverse events observed between the treatment groups and placebo. In part two of the study, the efficacy of vibegron monotherapy on the primary endpoint – reduction in micturitions – was statistically significant and similar to results observed in part one. The incidence of dry mouth was higher among patients treated with tolterodine alone or given concomitantly with vibegron, versus those treated with vibegron monotherapy.

In 2017, Urovant licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Earlier this year, Urovant initiated an international Phase 3 clinical program to evaluate the efficacy and safety of vibegron in adults with symptoms of OAB. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration.

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 Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 agonist being evaluated for the treatment of OAB 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’s second product candidate, hMaxi-K, 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.comwww.urovant.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron, report results of its Phase 3 clinical trial, and develop additional treatments for urologic diseases. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Urovant’s Registration Statement on Form S-1, which was filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on September 26, 2018, as well as any other future filings with the SEC available at www.sec.gov.

Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

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

Source: Urovant Sciences

Urovant Sciences
Kellie Lao
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Licenses Novel Gene Therapy for Overactive Bladder

  • There are no currently available FDA-approved gene therapy treatments for overactive bladder
  • Urovant expects to initiate Phase 2 hMaxi-K study in 2019

BASEL, Switzerland and IRVINE, Calif., August 28, 2018/PRNewswire – Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing therapies for urologic conditions, today announced it has licensed a novel investigational gene therapy for patients with overactive bladder (OAB) symptoms who have failed oral pharmacologic therapy.

Urovant has licensed global rights for the development and commercialization of hMaxi-K from Ion Channel Innovations. There are no currently available FDA-approved gene therapy treatments for overactive bladder.

hMaxi-K 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 hMaxi-K to be generally well tolerated. Clinical 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.

“We are pleased to add the gene therapy hMaxi-K to our clinical development portfolio. We are eager to study the potential of hMaxi-K as an alternative therapy for OAB patients who are not getting adequate relief from other therapies,” said Keith A. Katkin, President and Chief Executive Officer of Urovant. “Urovant also has access to gene therapy expertise through the Roivant family of companies.”

Urovant plans to meet with the FDA and initiate a Phase 2 clinical study in 2019 to investigate hMaxi-K as a novel treatment for OAB patients who have not responded to other pharmacological therapies.

Earlier this year, Urovant initiated a Phase 3 clinical trial program for vibegron, an investigational oral β3-adrenergic agonist being studied as a second-line treatment in adults with symptoms of OAB. Urovant expects to report top-line results for its Phase 3 trial of vibegron next year.

About Overactive Bladder
Overactive bladder is a clinical condition characterized by the sudden urge to urinate, with or without accidental urinary leakage, and usually with increased frequency. 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 and anxiety and have a negative impact on quality of life.2

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s lead product candidate, vibegron, is a potent and selective β3-adrenergic agonist being developed for an oral, once-daily treatment for 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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of hMaxi-K and vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost and timing of Urovant’s product development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of hMaxi-K and vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. hMaxi-K and vibegron are investigational and have not been approved by the U.S. Food and Drug Administration.

These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

 

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

 

Contacts

Investor inquiries: Investors@Urovant.com

Media inquiries: Media@Urovant.com

Urovant Sciences Appoints Sef Kurstjens and Pierre Legault to its Board of Directors

BASEL, Switzerland and IRVINE, Calif., July [9], 2018 /PRNewswire/ — Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the appointments of Sef Kurstjens, M.D., Ph.D. and Pierre Legault to its board of directors.

“I am excited that Sef Kurstjens and Pierre Legault have agreed to join the Urovant board,” said Keith Katkin, President and Chief Executive Officer of Urovant. “Both Sef and Pierre are accomplished executives with significant experience in the biopharmaceutical industry.”

“I am also pleased by the addition of Sef and Pierre to our board,” said Mayukh Sukhatme, President of Roivant Pharma and the incoming chairman of the Urovant board of directors. “We believe there are big things ahead for Urovant and we look forward to benefiting from Sef’s and Pierre’s expertise and counsel as we grow to meet the unmet medical needs of urology patients.”

Dr. Kurstjens and Mr. Legault join Keith Katkin, Mayukh Sukhatme, M.D. and Matthew Gline on the Urovant board of directors.

Dr. Kurstjens has over 27 years of biotech and pharmaceutical drug development experience, having most recently served as Chief Medical Officer at Astellas Pharma Inc. from 2013 to 2018. Dr. Kurstjens had responsibility for Astellas’ Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance and Quality Assurance divisions, and was a member of the Corporate Executive Committee. Dr. Kurstjens also served as President and Chief Executive Officer at Agensys, Inc., an affiliate of Astellas, from 2010 to 2013.

Prior to joining Astellas, Dr. Kurstjens served as Chief Medical Officer and Head of Global Drug Development at Allergan plc from 2007 to 2013, where he led all Global Drug Development, Clinical Operations, and Drug Safety for the Urology, Neurology, Ophthalmology and Dermatology global therapeutic areas. Dr. Kurstjens received his training in medicine and physiology at the University of the Witwatersrand Medical School in Johannesburg, South Africa.

“I am delighted to join the board of a company focused on meeting the needs of urology patients and I look forward to working with Keith and the rest of Urovant’s highly experienced management team,” said Dr. Kurstjens.

Mr. Legault has over 35 years of experience in the pharmaceutical and biotechnology industries. He currently serves as the Chairman of the board of directors for both Artios Pharma Limited and Poxel SA, as well as a member of the board of directors of Syndax Pharmaceuticals Inc. and Clementia Pharmaceutical Inc. Mr. Legault’s previous roles include serving as Chief Executive Officer of Prosidion Ltd., a subsidiary of Astellas, Chief Financial Officer of OSI Pharmaceuticals, Inc., and various global positions, including President, Chief Executive Officer and Chief Financial Officer at several legacy companies of the Sanofi-Aventis group. Mr. Legault has also served on the board of directors of several other healthcare companies, including Regado Biosciences, Inc. and ARMO Biosciences, Inc. He earned his B.B.A. from HEC Montreal and his M.B.A. from McGill University.

“I am very excited to join the Urovant board of directors,” said Mr. Legault. “Having devoted most of my career to the development and commercialization of therapies in multiple disease areas, I look forward to leveraging my experience to support Urovant as it develops innovative urological drugs.”

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s product candidate, vibegron, is an oral, once-daily, small molecule that, based on in vitro data, is a potent and highly selective beta-3 agonist. Vibegron is currently being evaluated in a large, international pivotal Phase 3 clinical trial for the treatment of overactive bladder (“OAB”). Vibegron is also being evaluated for two additional potential indications, treatment of OAB in men with benign prostatic hyperplasia and the treatment of pain associated with irritable bowel syndrome.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost and timing of Urovant’s product development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration or any comparable federal agency in any other jurisdiction.
These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

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http://www.urovant.com

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