Urovant Sciences Initiates Part 2 of Phase 3 COURAGE Study of Vibegron for Overactive Bladder in Men with Benign Prostatic Hyperplasia
“We are pleased to announce that, after reviewing the safety data from part 1 of the COURAGE trial, the independent Data Safety Monitoring Board (DSMB) agreed that the trial can now move to part 2, which will assess both efficacy and safety of vibegron in men with OAB and BPH,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant. “This is a pivotal milestone for this development program as there are currently no
About the COURAGE Phase 3 Trial
The COURAGE study is a randomized, double blind, placebo-controlled trial in men who are experiencing OAB symptoms, while also taking BPH medications. For part 2 of the trial, approximately 1,000 male patients with OAB and BPH will be randomized to receive either 75 mg of vibegron or placebo daily for 24 weeks. The co-primary endpoints are the reduction from baseline in average number of micturitions and urgency episodes per 24 hours. Key secondary endpoints are reduction in nocturia episodes (awakening at night to void), prostate symptom scores, and safety.
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,” “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 Urovant’s plans to advance the clinical development of vibegron in patients with OAB and BPH and the advancement of its COURAGE study. 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; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the