Urovant Sciences Initiates Patient Enrollment in Phase 2a Clinical Trial for Vibegron in Patients with Abdominal Pain Due to Irritable Bowel Syndrome
- Category: Small Molecules
- Published on Thursday, 03 January 2019 15:38
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BASEL, Switzerland & IRVINE, CA, USA I January 3, 2019 I Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, announced the company enrolled its first patient in a Phase 2a clinical trial evaluating vibegron in patients with abdominal pain due to irritable bowel syndrome (IBS) on December 31, 2018.
The company’s investigational new drug application was recently accepted by the U.S. Food and Drug Administration. There are no currently marketed drugs indicated specifically for IBS-associated pain.1
The Phase 2a trial is a double-blind, placebo-controlled study in women with abdominal pain due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M). The study is expected to enroll approximately 200 patients in the United States, randomized to receive either 75 mg of vibegron or placebo, administered orally once daily for a 12-week period. The primary endpoint is the proportion of patients who achieve at least a 30 percent improvement in the average worst abdominal pain score at week 12. Other clinical endpoints include Global Improvement Scale ratings, stool symptoms and safety.
Vibegron is an investigational oral beta-3 adrenergic receptor agonist currently being assessed for the treatment of overactive bladder. Urovant recently announced the completion of enrollment in its international Phase 3 clinical trial evaluating the safety and efficacy of vibegron as treatment for adults with symptoms of overactive bladder. Data available to date indicate vibegron is well tolerated. Vibegron has not been approved for commercialization by the U.S. Food and Drug Administration.
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About Irritable Bowel Syndrome Related Pain
Irritable bowel syndrome (IBS) is characterized by recurrent abdominal pain associated with two or more of the following symptoms: defecation, change in stool frequency, and/or change in stool form or appearance. In the United States, approximately 30 million to 40 million have IBS symptoms, 30% of whom consult with a physician.2 Approximately 80% of these patients identify pain as a symptom contributing to the severity of their IBS3 and it is estimated 7.2 million to 9.6 million IBS patients suffer from IBS-associated pain2. While there are approved therapies for IBS with constipation and IBS with diarrhea, these therapies do not adequately address IBS-associated pain. Moreover, there are no currently marketed drugs indicated specifically for IBS-associated pain.1
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.com.
- International Foundation for Gastrointestinal Disorders, accessed December 14, 2018; https://www.aboutibs.org/treating-ibs-pain.html
- Canavan C., et al., Clinical Epidemiology 2014
- Lovell RM, Ford AC, et al., Clin Gastroenterol Hepatol. 2012; Drossman DA, et al., J Clin Gastroenterol 2009
SOURCE: Urovant Sciences