Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: David Staskin*, Boston, MA, Jeffrey Frankel, Burien, WA, Susann Varano, Milford, CT, Jihao Zhou, Rachael Jankowich, Paul N Mudd, Irvine, CA
Introduction: Vibegron is a novel, once-daily, oral β3-adrenoceptor (AR) agonist in development for treatment of patients (pts) with overactive bladder (OAB). Vibegron is highly selective, demonstrating a >9000-fold selectivity for β3-AR over β2-AR and β1-AR in cell-based in vitro assays. The primary objective of this study was to evaluate the safety and efficacy of vibegron compared to placebo in pts with symptoms of OAB.
Methods: This multicenter, international trial enrolled pts ≥18 yrs with OAB for ≥3 months with ≥8 micturitions/24 h and ≥1 urge urinary incontinence (UUI) episodes/24 h (OAB wet criteria), or with <1 UUI/24 h and ≥3 urgency episodes/24 h (OAB dry criteria). Pts were randomized 5:5:4 to 75 mg vibegron (Vib), placebo (PBO), and extended release tolterodine 4 mg (Tol) once daily (qd) for 12 weeks (wks).
Results: This abstract is being submitted without the primary endpoint results, under the embargo precept in the late breaking submission guidelines, because the trial will not conclude until after the submission deadline.
Conclusions: Conclusions based on observed results
Source of Funding: Urovant Sciences Inc.