The phase 3 URO-901-3005 study met its 2 co-primary end points with vibegron demonstrating a reduction in micturition episodes and urgency episodes from baseline to 12 weeks.
The phase 3 URO-901-3005 study (NCT03902080) of vibegron (Gemtesa) in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH) has met its co-primary end points, Sumitomo Pharma announced in a news release.1
"Millions of men struggle with the burdensome symptoms of OAB which are further exacerbated by BPH, including frequent and urgent need to urinate, difficulty or delay in urinating, and waking up in the middle of the night to urinate. These symptoms can have a significant negative impact on patients' lives, including long-term sleep deprivation. These data from URO-901-3005 demonstrate the potential of vibegron and speaks to our commitment to addressing the unmet needs of those experiencing urologic conditions,” Chief Medical Officer at Sumitomo Pharma America (SMPA), Armin Szegedi, MD, PhD, said in the news release.1
In total, the multicenter, randomized, double-blind, parallel-group, fixed-dose URO-901-3005 study2 enrolled 1105 men with OAB symptoms who were receiving therapy with either an alpha blocker monotherapy or an alpha blocker plus 5-alpha reductase inhibitor for BPH. Patients in the study received 75 mg vibegron once daily.
The co-primary end points for the study were the change in the average number of micturition episodes and urgency episodes per day from baseline to 12 weeks. Secondary end points of the study were changes in the average number of nocturia episodes, urge urinary incontinence episodes, International Prostate Symptom Storage (IPSS) scores, and the average volume voided per micturition.
At 12 weeks, data showed that the co-primary end points were met, with patients who received vibegron experiencing significant reductions in micturition (-2.04; P < .0001) and urgency episodes (-2.88; P < .0001) at baseline compared with patients who received placebo (-1.30 and -1.93, respectively).
Additionally, all secondary end points in the study were met at 12-week follow-up. Patients who received vibegron experienced significant reductions in the average number of nocturia episodes per night compared with patients who received placebo (-0.88 and -0.66, respectively; P = .0015), as well as in the average number of urge urinary incontinence episodes per day (-2.19 and -1.39, respectively; P = .0034).
The vibegron cohort also demonstrated a greater reduction in IPSS scores compared with the placebo group (-3.0 and -2.1, respectively; P < .0001). Further, men who received vibegron experienced an average increase in volume voided per micturition of 25.63 mL, compared with 10.56 mL among patients who received placebo (P < .0001).
Overall, the treatment was well tolerated and safety signals were consistent with previously reported studies. Serious adverse events were experienced by 4.3% of patients who received vibegron and 2.9% of patients who received placebo.
Adele Gulfo, the Chief Executive Officer of Biopharma Commercial Unit at SMPA, added in the news release,1 "OAB is often misconstrued as a normal part of aging instead of a clinical condition. Since its launch, vibegron has helped more than 200,000 patients and long-term care residents living with OAB. We are committed to continued innovation and bringing novel treatment options to those living with often underdiscussed urologic conditions."
Patients who completed the phase 3 URO-901-3005 study were eligible to continue to an extension study, URO-901-3006 (NCT04103450), which assessed the long-term safety, tolerability, and efficacy of vibegron in this patient population.3
At 52-week follow-up, patients who received vibegron continued to demonstrate reductions in the average number of micturition and urgency episodes per day. Further, reductions in the average number of nocturia or urge urinary incontinence episodes, International Prostate Symptom Storage scores, and an increase in average volume voided per micturition were also maintained among patients in the vibegron cohort. No new safety signals emerged.
Investigators expect results to be presented at future medical congresses.
1. Sumitomo Pharma announces positive topline results from phase 3 clinical studies evaluating vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. News release. Sumitomo Pharma America. Published online and accessed September 11, 2023. https://www.prnewswire.com/news-releases/sumitomo-pharma-announces-positive-topline-results-from-phase-3-clinical-studies-evaluating-vibegron-in-men-with-overactive-bladder-symptoms-receiving-pharmacological-therapy-for-benign-prostatic-hyperplasia-301923356.html
2. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Study to evaluate the efficacy, safety and tolerability of vibegron in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH). Last updated September 21, 2022. Accessed September 11, 2023. https://clinicaltrials.gov/study/NCT03902080
3. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Extension study of vibegron in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH). Last updated June 2, 2023. Accessed September 11, 2023. https://clinicaltrials.gov/study/NCT04103450