- Interim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder (OAB) and urge urinary incontinence (UUI) will be featured in a late breaker presentation by Kenneth M. Peters, M.D. during Friday morning’s plenary session.
- New analyses of data from the Phase 3 EMPOWUR Extension Study of GEMTESA® (vibegron) 75 mg will be presented during Sunday morning’s podium session by:
- Jeffrey Frankel, M.D., who will report on an analysis of long-term efficacy and safety in patients aged 65 years or above.
- David Staskin, M.D., who will present an analysis of long-term patient-reported outcomes for OAB
In addition, two podium presentations at AUA2022 will feature new analyses of data from the EMPOWUR 40-week extension trial of GEMTESA® (vibegron) 75 mg, a Phase 3, randomized, double blind, active-comparator controlled multicenter study to evaluate long-term safety and efficacy in patients with symptoms of OAB. GEMTESA is approved by the U.S. Food and Drug Administration (FDA) for the treatment of OAB in adults with symptoms of UUI, urgency, and urinary frequency.
“Overactive bladder remains a condition in need of additional treatment options. We look forward to sharing new data related to the use of GEMTESA in the OAB patient population as well as providing an initial read-out on the progress of our investigational gene therapy, URO-902,” said Sef Kurstjens, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Urovant Sciences. “We believe that URO-902 could potentially offer a new treatment option for patients with overactive bladder who have been inadequately managed by oral pharmacologic therapy, if approved by the FDA. The two podium presentations on GEMTESA will also add to the scientific and medical community’s understanding of this important therapy.”Data on the potential novel gene therapy, URO-902, will be presented during Friday morning’s plenary session:
Late-Breaking Abstract PLLBA-03, presented by Kenneth M. Peters, M.D., principal investigator, and Chief of the Department of Urology at Beaumont Hospital, Royal Oak; Medical Director of the Beaumont Women’s Urology and Pelvic Health Center and professor and Chair of Urology of the Oakland University William Beaumont School of Medicine in Rochester, Michigan., titled, “Efficacy and Safety of a Novel Gene Therapy (URO-902; pVAX/hSlo) in Female Patients with Overactive Bladder and Urge Urinary Incontinence: Results from a Phase 2a Trial.” This presentation will take place on Friday, May 13, at 11:21 to 11:29 a.m. CDT during the plenary session in the Ernest N. Morial Convention Center, Great Hall A.
Data on GEMTESA will also be featured in two podium presentations at the conference on May 15, 2022:
- PD38-11: “‘Long-Term Efficacy and Safety of Vibegron for Overactive Bladder in Patients ≥65 Years Old: Analysis from the EMPOWUR Extension Trial,”’ to be presented by Jeffrey Frankel, M.D., Medical Director, Seattle Urology Research Center, Seattle, Washington. (8:40 to 8:50 a.m. CDT in the Ernest N. Morial Convention Center, Room 244)
- PD38-12: “‘Long-Term Patient-Reported Outcomes of Vibegron for Overactive Bladder: Analyses from the EMPOWUR Extension Trial,”’ to be presented by David Staskin, M.D., Associate Professor of Urology, Tufts University School of Medicine. (8:50 to 9:00 a.m. CDT in the Ernest N. Morial Convention Center, Room 244)
Source: "Urovant Sciences To Present Interim Data From Phase 2A Study Of Potential Novel Gene Therapy, URO-902, And New Analyses Of Data From Phase 3 EMPOWUR Extension Trial Of GEMTESA® (Vibegron) 75 Mg At 2022 American Urological Association Annual Meeting | Urovant Sciences". 2022. Urovant Sciences.