Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate

  • New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate
  • Phase 3 EMPOWUR trial post-hoc subgroup analyses showed once-daily GEMTESA was associated with significantly reduced daily urgency episodes and micturitions in patients with OAB wet and dry (with and without urge urinary incontinence [UUI] per diary day, respectively) vs. placebo
  • Presented at the virtual AUA 2021 annual meeting, these data further support safety and efficacy of GEMTESA for treatment of OAB in patients with symptoms of UUI, urgency, and urinary frequency
San Francisco, CA (UroToday.com) -- Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today presented data on GEMTESA® (vibegron) 75 mg in patients with overactive bladder (OAB) at the 2021Annual Meeting of the American Urological Association (AUA) held virtually from September 10-13, 2021.
 
“We are delighted to present these important additional data confirming the efficacy and safety profile of GEMTESA,” said Cornelia Haag-Molkenteller, MD, PhD, Chief Medical Officer of Urovant Sciences. “The data from the ambulatory blood pressure study demonstrating no statistically significant or clinically relevant effect on blood pressure with GEMTESA, a beta-3 agonist to treat OAB, will be important for physicians and patients suffering from OAB.”

In a randomized, double-blind study of patients with OAB, once-daily treatment with GEMTESA was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate. The study was described in a virtual podium presentation (#PD66) by Michael A. Weber, MD, Professor of Medicine at the State University of New York Downstate College of Medicine, Brooklyn, NY. The presentation was entitled, “Effects of Vibegron on Ambulatory Blood Pressure in Patients with Overactive Bladder: Results from a Double-Blind Study.”
 
“This standalone study was conducted to understand the potential effects of GEMTESA on heart rate and blood pressure in a dedicated study using ambulatory blood pressure measurements,” said Dr. Weber. “The new data confirm that GEMTESA has no statistically significant or clinically relevant impact on blood pressure compared to placebo.”

Results from Ambulatory Blood Pressure Study

The ambulatory blood pressure study enrolled 214 patients with OAB, aged between 40-75 years. The mean age was 59.3 years and 74.6% of all patients were female. Overall, 35% of patients had pre-existing hypertension, which was present in slightly more patients in the GEMTESA group than in the placebo group. Demographic characteristics were well balanced between the groups.
 
The primary endpoint changed from baseline to day 28 in mean daytime ambulatory systolic blood pressure and was evaluated against a criterion of 3.5 mmHg for the upper limit of the confidence interval. Key secondary endpoints were changed from baseline to day 28 in mean daytime ambulatory diastolic blood pressure and heart rate and change from baseline to day 28 in mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, and heart rate. Safety was assessed through adverse event reporting and safety lab tests.
 
Individuals with valid 24-hour ambulatory blood pressure readings at baseline were randomly assigned 1:1 to receive once-daily GEMTESA or placebo for 28 days. On day 28, patients returned to the clinic for a second 24-hour assessment. At baseline, in-clinic mean baseline systolic blood pressure, diastolic blood pressure, and heart rate was generally similar between groups. There were no statistically significant or clinically relevant differences in mean daytime or mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, or heart rate after 28 days of treatment with GEMTESA compared with placebo.
 
Serious treatment-emergent adverse events occurred in 1 patient in each group (GEMTESA: postoperative pain; placebo: hypoglycemia). Hypertension was the most frequently reported treatment-emergent adverse event in both the placebo (4 patients) and the GEMTESA treatment group (5 patients); however, no event of hypertension with GEMTESA was considered related to study treatment. Of the 5 reported events of hypertension with GEMTESA, 1 occurred in a patient taking phentermine, which was a prohibited medication as it is known to increase blood pressure.
 
EMPOWUR Subgroup Analyses

Post hoc subgroup analyses of data from the international, randomized, placebo- and active-controlled Phase 3 EMPOWUR trial were the subject of a virtual poster presentation (#MP63) by David Staskin, MD. The principal investigator of the EMPOWUR study, Dr. Staskin is a urologist with St. Elizabeth’s Medical Center, and Associate Professor of Urology at Tufts University School of Medicine, Boston. The virtual poster was entitled, “Vibegron for the Treatment of Patients with Dry Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.”
 
“The data from the subgroup analyses indicate that compared with placebo, once-daily GEMTESA 75 mg was associated with significant reductions in daily urgency episodes and urinary frequency also in patients with OAB who did not have urinary urge incontinence,” said Dr. Staskin. “These positive effects were seen in patients with OAB wet, who have urinary incontinence, and OAB dry, who do not. This suggests that GEMTESA is similarly effective for these endpoints in patients with OAB wet and dry.”
About the EMPOWUR Trial

The EMPOWUR trial was an international, randomized, double-blind, placebo, and active comparator-controlled Phase 3 clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate and urge incontinence or leakage. A total of 1,518 patients were randomized across 215 study sites into one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine extended-release (ER) 4 mg administered orally once daily.

References:

  1. Staskin, D., Frankel, J., Varano, S., Shortino, D., Jankowich, R., Mudd, P.N. Jr. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020 Aug;204(2):316-324. doi: 10.1097/JU.0000000000000807. Epub 2020 Feb 18. PMID: 32068484.
  2. Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9
  3. Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.


Source: WIRE, BUSINESS. 2021. "Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (Vibegron) 75 Mg In Overactive Bladder Was Not Associated With Statistically Significant Or Clinically Meaningful Effects On Blood Pressure Or Heart Rate". Businesswire.Com. 
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