- Vibegron Met Both Co-Primary Endpoints Demonstrating Statistically Significant Reductions in Daily Micturition and Urgency Episodes, Compared to Placebo at Week 12
- Vibegron Met All Secondary Endpoints, Including a Reduction in Nocturia Episodes Versus Placebo at Week 12
- Open-label Extension Trial Showed Reductions in Daily Micturition and Urgency Episodes Were Maintained Up to 52 Weeks
- Vibegron Was Well-Tolerated and Demonstrated a Consistent Safety Profile with No New Safety Signals Compared to Prior Overactive Bladder Studies
Reno, Nevada (UroToday.com) -- Sumitomo Pharma Co., Ltd. companies, Sumitomo Pharma America, Inc. (SMPA) and Sumitomo Pharma Switzerland (SMPS), announced that the Phase 3 URO-901-3005 clinical study of vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), which is being investigated in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH), met its co-primary endpoints at Week 12 compared to placebo. The co-primary endpoints include both change from baseline in the average number of micturition (urination) episodes per day and change from baseline in the average number of urgency episodes (the sudden urge to urinate that is difficult to control) per day.
URO-901-3005 was a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study which evaluated the efficacy, safety, and tolerability of vibegron versus placebo over 24 weeks in 1,105 men with OAB symptoms receiving pharmacological therapy for BPH. In the primary efficacy analysis, once-daily vibegron met the co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline (least squares means) in daily micturitions (-2.04 [SE: 0.109]; p<0.0001) and in daily urgency episodes (-2.88 [SE: 0.164]; p<0.0001) compared to placebo (-1.30 [SE: 0.109] and -1.93 [SE: 0.164], respectively).
In the study, patients receiving vibegron met all secondary endpoints at Week 12, including a statistically significant reduction in the key secondary endpoint of average number of nocturia episodes per night compared to placebo (-0.88 compared to -0.66; p=0.0015). Additionally, patients receiving vibegron showed statistically significant reductions from baseline compared to placebo in the average number of urge urinary incontinence episodes per day (-2.19 compared to -1.39; p=0.0034) and International Prostate Symptom Storage score (-3.0 compared to -2.1; p<0.0001), while a statistically significant increase was seen in the average volume voided per micturition (25.63 mL compared to 10.56 mL; p<0.0001).
"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," said Armin Szegedi, M.D., Ph.D., Chief Medical Officer at SMPA. "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.""We are pleased to share the results of this study, which underscores the promise of one of our key marketed assets beyond its initial approved indication," said Myrtle Potter, President and Chief Executive Officer of SMPA. "With these positive data, we look forward to exploring the potential of vibegron as an option for men experiencing OAB symptoms and BPH."
The safety and tolerability of vibegron was assessed throughout the study. Overall, vibegron was well-tolerated throughout the study and demonstrated a consistent safety profile with no new safety signals compared to prior OAB studies. The most common adverse events occurring in at least 2% of the vibegron 75 mg group and at a rate higher than placebo were hypertension (9.0% and 8.3%, respectively), COVID-19 (4.0% and 3.1%, respectively), and urinary tract infection (2.5% and 2.2%, respectively). The frequency of serious adverse events was similar across treatment arms (4.3% in vibegron, 2.9% in placebo).
"OAB is often misconstrued as a normal part of aging instead of a clinical condition," said Adele Gulfo, Chief Executive Officer of Biopharma Commercial Unit at SMPA. "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 URO-901-3005 were eligible to continue onto URO-901-3006, an open-label, 28-week extension study evaluating the safety, tolerability, and efficacy of vibegron 75 mg in men with symptoms of OAB who are receiving pharmacological therapy for BPH. Results from the open-label extension study show reductions in the average number of micturitions per day and urgency episodes per day were maintained up to 52 weeks. Reductions in nocturia, urge urinary incontinence, International Prostate Symptom Storage score, and increase in average volume voided per micturition were also maintained up to 52 weeks. Overall, vibegron was well-tolerated throughout the study and demonstrated a consistent safety profile with no new safety signals compared to prior studies.
Results will be presented at future medical congresses. Use of GEMTESA in men with symptoms of OAB receiving pharmacological therapy for BPH is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Source: Sumitomo Pharma Co. (2023). 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 [Press release]. https://news.us.sumitomo-pharma.com/2023-09-11-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.