“There are limited clinical data available in men who are taking medications for symptoms associated with benign prostatic hyperplasia, yet continue to experience overactive bladder symptoms,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant.
An estimated 4.5 million men in
“COURAGE is an important development program for vibegron as there is currently no
About the COURAGE Phase 3 Trial
The COURAGE study is a randomized, double blind, placebo-controlled trial in men with BPH who are also taking BPH medications but continue experiencing OAB symptoms. The study will be conducted in two phases, with the first phase focusing on safety and the second phase assessing efficacy and safety. Approximately 1,000 patients who meet eligibility requirements will be randomized to receive either 75 mg of vibegron or placebo daily for 24 weeks.
The co-primary efficacy endpoints will be measured at 12 weeks and nclude:
- Change from baseline in the average number of micturitions per 24 hours
- Change from baseline in the average number of urgency episodes per 24 hours
Secondary endpoints include change from baseline in the average number of nocturia episodes per night, which is awakening at night to use the bathroom to urinate.
The duration for the double-blind study is 24 weeks. In addition, a 28-week open-label extension study will evaluate the long-term safety and efficacy of vibegron in men with OAB symptoms and on another therapy for BPH. Adverse events will be monitored throughout the trial. The 75 mg dose is the same dose tested in the international EMPOWUR Phase 3 trial for vibegron in patients with OAB. The Company recently announced positive topline results from the pivotal Phase 3 EMPOWUR study.
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “suggest,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions, the Company’s initiation of the COURAGE study, as well as the plan to develop vibegron for symptoms of OAB in men who are receiving pharmacological treatment for BPH.
The Company’s forward-looking statements are based on management’s current expectations and beliefs, and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Company’s operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in the Company’s filings with the
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