The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients¹

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study^2,3

At Week 12, safety and efficacy were evaluated in over 1500 patients with symptoms of overactive bladder (OAB)^2,3
- GEMTESA demonstrated a statistically significant reduction of all 3 key OAB symptoms* vs placebo at 12 weeks—including urgency^2,4†
- ~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes at Week 12 vs 38% with placebo^3‡
505 patients continued on to a 40-week, phase 3, randomized, double-blind, active-controlled, multicenter extension study that evaluated the safety and efficacy of GEMTESA^1§

*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI).⁴

^†The efficacy of GEMTESA was evaluated in a 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%), with a mean age of 60 (range 18 to 93) years.^2,3

^‡Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.³

^§A limitation of this study is the potential for selection bias for patients who elected to enter the EMPOWUR extension.¹

Safety and efficacy of GEMTESA were evaluated at 52 weeks¹

Reductions in UUI per 24 hours at 52 weeks vs active control^1,3*

Extension Study Design

*Baseline: 3.18 for GEMTESA; 3.0 for active control.³

Urge urinary incontinence (UUI)^1,3*

Graph showing reductions in urge urinary incontinence (UUI). Patients taking GEMTESA® had significant reductions in average daily UUI episodes at 12 weeks. — Values
LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=405) -0.8 -1.0 -1.2 -1.4
GEMTESA 75mg (n=403) -1.4 -1.7 -1.8 -2.0

LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=405)	-0.8	-1.0	-1.2	-1.4
GEMTESA 75mg (n=403)	-1.4	-1.7	-1.8	-2.0

*Baseline: 3.18 for GEMTESA; 3.0 for active control.³

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

Please see extension study design above.

Micturition frequency^1,3*

Graph showing reductions in average daily micturition frequency at 12 weeks. Patients taking GEMTESA® had significant improvements in micturition frequency. — Values
LS MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=520) -0.5 -0.7 -1.0 -1.3
GEMTESA 75mg (n=526) -0.9 -1.2 -1.6 -1.8

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.5	-0.7	-1.0	-1.3
GEMTESA 75mg (n=526)	-0.9	-1.2	-1.6	-1.8

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

*Baseline: 11.32 for GEMTESA; 11.33 for active control.³

Please see extension study design above.

Reductions in urgency episodes
per 24 hours at 52 weeks vs
active control¹*

*Baseline: 8.0 for GEMTESA; 8.03 for active control.³

Please see extension study design above.

Urgency episodes^1,3*

Graph showing reductions in average daily urgency episodes. GEMTESA® features urgency reduction data in its label. — Values
LS MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=520) -0.9 -1.1 -1.6 -2.0
GEMTESA 75mg (n=526) -1.5 -1.9 -2.4 -2.7

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.9	-1.1	-1.6	-2.0
GEMTESA 75mg (n=526)	-1.5	-1.9	-2.4	-2.7

*Baseline: 8.0 for GEMTESA; 8.03 for active control.³

Reductions in UUI episodes of 100% at 12 weeks and at 52 weeks vs placebo and active control, respectively^1,3*^†

Please see extension study design above.

100% reduction in UUI episodes^1,3

Graph showing achievement of ≥75% reduction in daily urge urinary incontinence (UUI) episodes. 52% of GEMTESA® patients vs ~37% of placebo patients. — Values
% OF PATIENTS ACHIEVING ≥75% REDUCTION IN UUI
12 Weeks
Placebo (n=405) 36.8%
GEMTESA 75mg (n=403) 52.4%

% OF PATIENTS ACHIEVING ≥75% REDUCTION IN UUI
	12 Weeks
Placebo (n=405)	36.8%
GEMTESA 75mg (n=403)	52.4%

Reductions in UUI episodes of 100% at 12 weeks and at 52 weeks vs placebo and active control, respectively^1,3*^†

*Data were based on a key secondary endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 12 (n=403).³

^†Data were based on an exploratory endpoint analysis of OAB-wet patients with 100% reduction in UUI from baseline at Week 52 (n=143).³

Please see extension study design above.

EXTENSION STUDY DESIGN

More than 500 patients were studied
in the 40-week extension period¹

Study design description

A 12-week, phase 3, randomized, double-blind, placebo- and active-controlled, multicenter study evaluated the safety and efficacy of GEMTESA in 1500+ patients with symptoms of overactive bladder (OAB).^2,3

A 40-week, phase 3, randomized, double-blind, active-controlled, multicenter extension study evaluated the safety and efficacy of GEMTESA in 505 patients with symptoms of OAB.^1*

Values
2-week run-in period² 12-week, double-blind treatment period²
RANDOMIZATION
Placebo Placebo (n=540)
GEMTESA 75 mg (n=545)
Active control (n=430)
Week 0 Week 12

Diagram showing the structure of the GEMTESA® study. Over 1500 patients participated in the study. — Values
2-week run-in period² 12-week, double-blind treatment period²
RANDOMIZATION
Placebo Placebo (n=540)
GEMTESA 75 mg (n=545)
Active control (n=430)
Week 0 Week 12

2-week run-in period²	12-week, double-blind treatment period²
RANDOMIZATION
Placebo	Placebo (n=540)
GEMTESA 75 mg (n=545)
Active control (n=430)
Week 0	Week 12

*A limitation of this study is the potential for selection bias for patients who elected to enter the EMPOWUR extension.¹

Study endpoints^1-3

Efficacy at 12 weeks

Safety at 52 weeks

PRIMARY ENDPOINT

Change from baseline in average daily number of micturitions and urge urinary incontinence (UUI) episodes (wet OAB)

Incidence of treatment-emergent adverse events

At 12 weeks
(key secondary endpoint)

At 52 weeks

SECONDARY ENDPOINT

Change from baseline in average daily number of urgency episodes

Change from baseline at Week 52 in average daily number of:

Micturitions
UUI episodes (wet OAB)
Urgency episodes

At 12 weeks

At 52 weeks

100% REDUCTION IN UUI EPISODES

Secondary endpoint

Exploratory endpoint

Efficacy analyses were performed using the FAS-EXT, except for incontinence episode endpoints, which used the FAS-EXT-I.³

52-week patient demographics^1-3

YEARS OLD
MEAN AGE

78^%

FEMALE

22^%

MALE

78% OAB WET^†

22% OAB DRY^†

Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study

Inclusion criteria: symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^2†

^†OAB wet=average of ≥1 UUI episode per day. OAB dry=average of ≥3 urgency episodes and average of <1 UUI episode per day.³

^‡UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.²

ACh=anticholinergic; FAS-EXT=full analysis set extension; FAS-EXT-I=full analysis set extension for incontinence.

The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients1

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study2,3

Safety and efficacy of GEMTESA were evaluated at 52 weeks1

Reductions in UUI per 24 hours at 52 weeks vs active control1,3*

Urge urinary incontinence (UUI)1,3*

Values

Reductions in micturition frequency per 24 hours at 52 weeks vs active control1*

Micturition frequency1,3*

Values

Reductions in micturition frequency per 24 hours at 52 weeks vs active control1*

Reductions in urgency episodes per 24 hours at 52 weeks vs active control1*

Urgency episodes1,3*

Values

100% reduction in UUI episodes1,3

Values

More than 500 patients were studied in the 40-week extension period1

Study design description

Values

Study endpoints1-3

52-week patient demographics1-3

Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study

Inclusion criteria: symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day2†

The GEMTESA pivotal study had more than 1500 patients with OAB and the extension study had over 500 patients¹

GEMTESA (vibegron) was studied in a phase 3, randomized, double-blind, placebo- and active-controlled multicenter study^2,3

Safety and efficacy of GEMTESA were evaluated at 52 weeks¹

Reductions in UUI per 24 hours at 52 weeks vs active control^1,3*

Urge urinary incontinence (UUI)^1,3*

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

Micturition frequency^1,3*

Reductions in micturition frequency per 24 hours at 52 weeks vs active control¹*

Reductions in urgency episodes
per 24 hours at 52 weeks vs
active control¹*

Urgency episodes^1,3*

100% reduction in UUI episodes^1,3

More than 500 patients were studied
in the 40-week extension period¹

Study endpoints^1-3

52-week patient demographics^1-3

Inclusion criteria: symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^2†