Urovant Sciences Announces Publication of Subgroup Analysis of EMPOWUR Trial Showing Similar Efficacy for GEMTESA® in Dry and Wet Overactive Bladder Populations

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IRVINE, Calif. and BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new post-hoc analysis of data from the Phase 3 EMPOWUR trial of GEMTESA (vibegron) 75 mg in the International Journal of Clinical Practice. The peer-reviewed article is titled “Vibegron for the treatment of patients with dry and wet overactive bladder: a subgroup analysis of the EMPOWUR trial.” The article is available online and will be published in an upcoming print issue of the journal.

OAB is characterized by urgency and frequency with (wet OAB) or without (dry OAB) urge urinary incontinence (UUI). Although dry OAB affects a greater proportion of the OAB population, pharmacological treatment studies typically report outcomes in the overall OAB population or in patients with wet OAB. They also focus on UUI as the most bothersome symptom of an overactive bladder. Therefore, treatment guidelines do not discriminate between these patients and often neglect to address the need to manage the disruptive and central emergency symptom associated with overactive bladder. The post-hoc analysis was developed to compare the efficacy of vibegron versus placebo in wet and dry OAB populations.

“In this subgroup analysis of data from the EMPOWUR trial, vibegron was associated with significant reductions in urgency episodes and voiding (urine) compared to placebo in both dry and wet OAB populations,” said said lead author Jeffrey Frankel, MD, medical director, Seattle Urology Research Center. “This indicates that vibegron may be equally effective in improving these parameters in patients with and without urge urinary incontinence.”

These results are consistent with overall EMPOWUR data showing favorable long-term safety, tolerability and efficacy in patients with overactive bladder; these were published in the Journal of Urology in May 2021.1

In the EMPOWUR study, patients were randomized 5:5:4 to receive vibegron 75 mg once daily, placebo, or tolterodine extended-release 4 mg, respectively, for 12 weeks. Serious adverse events associated with vibegron occurred at rates comparable to placebo (1.5 versus 1.1% for vibegron versus placebo, respectively) in EMPOWUR; the most common treatment-emergent adverse events (TEAEs) with a higher incidence for vibegron than for placebo were headache and nasopharyngitis. The incidence of hypertension was similar between the vibegron and placebo treatment groups.

“This latest publication further confirms the role of GEMTESA as a useful treatment option for both dry OAB and wet OAB patient types, making it an important option for people living with OAB,” said Salim Mujais, Vice -Senior President of Clinical Development, Urovant Sciences. “This condition affects approximately 30 million Americans and may impact activities of daily living. Clinically significant decreases in urinary urgency may address an unmet need in these patients.

About the EMPOWUR trial

The EMPOWUR trial was an international Phase 3, randomized, double-blind, placebo-controlled, active-comparator clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, a sudden urge to urinate, and urge or leak incontinence. A total of 1,518 patients were randomized across 215 study sites to one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once a day ; placebo administered orally once daily; or tolterodine ER 4 mg taken orally once daily.

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), urge incontinence (involuntary loss of urine immediately after an urgent need to urinate), frequent urination (usually eight times or more in 24 hours) and nocturia (waking up more than twice in the night to urinate).1

Approximately 30 million Americans suffer from bothersome symptoms of an overactive bladder, which can significantly impair a patient’s daily activities.1,2

About GEMTESA

GEMTESA is a prescription medicine for adults used to treat the following symptoms of a condition called overactive bladder:

  • urge urinary incontinence: a strong need to urinate with leaks or pee accidents

  • urgency: the need to urinate right away

  • frequency: urinating often

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before taking GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have difficulty emptying your bladder or your urine stream is weak; taking medications containing digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; tell your doctor if you are pregnant or plan to become pregnant); you are breast-feeding or plan to breast-feed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you are taking GEMTESA).

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medications, vitamins and herbal supplements. Know the medications you take. Keep a list to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA can cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your risk of not being able to empty your bladder, particularly if you have a bladder outlet obstruction or are taking other medicines for the treatment of overactive bladder. Tell your doctor immediately if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infections, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infections. These are not all the possible side effects of GEMTESA. For more information, consult your doctor or pharmacist.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Please click here for complete product information for GEMTESA.

About Urovant Sciences

Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for areas of unmet need, with a particular focus on urology. The company’s flagship product, GEMTESA (vibegron), is a small molecule beta-3 agonist taken orally once daily (75 mg) for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, d urgency and urinary frequency. GEMTESA was approved by the US FDA in December 2020 and launched in the US in April 2021. GEMTESA is also being evaluated for the treatment of overactive bladder in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy in development for patients with overactive bladder who have failed oral pharmacological therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com or follow us on Twitter or LinkedIn.

On Sumitovan Biopharma Ltd.

Sumitovant is a global biopharmaceutical company that leverages data-driven insights to rapidly accelerate the development of potential new therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries – Urovant, Enzyvant, Spirovant, Altavant – and the use of embedded computing technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline. from early to late stage investigational assets for other serious conditions. Sumitovant, a wholly owned subsidiary of Sumitomo Pharma, is also the majority shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovant.com.

About Sumitomo Pharma Co., Ltd.

Sumitomo Pharma is among the top ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets including Japan, the United States, China and other Asian countries, with more than 7,000 employees in the world. Sumitomo Pharma defines its corporate mission as follows: “To contribute broadly to society through the creation of value based on innovative research and development activities for the improvement of health care and a more fulfilling life worldwide. Additional information about Sumitomo Pharma is available on its website at https://www.sumitomo-pharma.com.

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the United States and other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Science. All rights reserved.

1 https://www.auajournals.org/doi/10.1097/JU.0000000000001574

2 https://media.urovant.com/news-releases/news-release-details/urovant-sciences-announces-publication-positive-long-term.

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