Investor Presentaiton
Etrasimod: Phase 2 Efficacy in Ulcerative Colitis (UC)
.
UC Efficacy Overview
Randomized placebo-controlled, dose-ranging, Phase
2 study (OASIS) evaluated the efficacy and safety of
etrasimod in moderate-to-severe UC patients over 12
weeks
• Cross trial comparison showed improved efficacy vs.
ozanimod on registration endpoints of clinical
remission and endoscopic improvement
•
•
•
Similar performance was observed on secondary
endpoints (clinical response, histologic remission)
Competitive efficacy seen across other approved and
emerging treatments in UC
⚫ Phase 3 (ELEVATE) results expected in Q1 2022
•
•
Ongoing GLADIATOR-UC study to provide clinical
evidence for use in moderate patients (expected read-
out in Q2/3 2023)
Potential best-in-class efficacy for UC and
Crohn's Disease
Competitive potential efficacy across
approved and emerging treatments
2Pfizer
Inflammation & Immunology
Etrasimod vs. Ozanimod in UC
NEW DATA
OASIS Post hoc Analysis - TOUCHSTONE Post hoc Analysis - TRUE NORTH Primary Endpoint
100%
ETR OASIS Ph2
80%
Clinical Remission (3-comp)
Week 12
Patients Achieving 3 Component Remission
60%
A=25.6; P=0.0002
40%
A = 9.3; P=0.0598
30.6%
20%
15.6%
5.6%
0%
Placebo
(n=54)
Etrasimod 1 Etrasimod 2
mg
mg
(n=52)
(n=50)
Patients Achieving 3 Component Remission
100%
OZANIMOD TOUCHSTONE Ph2
Clinical Remission (3-comp)
Week 8*
80%-
60%
A-16.2; P=0.0068
40%
A=92; P=0.1121
23.9%
20%
16.9%
7.7%
0%
Placebo
(n=65)
Ozanimod
Ozanimod 1
0.5 mg
(n=65)
mg
(n=67)
Patients Achieving 3 Component Remission
100%
OZANIMOD TRUE NORTH Ph3
Clinical Remission (3-comp)
Week 10
80%-
60%
A 124; P<0.0001
40%
18.4%
20%
6.0%
0%
Placebo
(n=216)
Ozanimod 1 mg
(n=429)
FDA Required Primary Endpoint used ELEVATE (etrasimod) and True North (ozanimod)
RB=0, SF≤1 with Improvement ≥1, Endo score ≤1
OASIS Secondary Endpoint - TOUCHSTONE Secondary Endpoint - TRUE NORTH Secondary Endpoint
Patients Achieving Endoscopic Improvement
100%
OASIS Ph2
Endoscopic Improvement
Week 12
80%
60%
A 24.4; P=0.0030
A-4.1; P=0.3059
40%
22.5%
17.8%
20%
0%
Placebo
(n-54)
41.8%
Etrasimod 1 Etrasimod 2
mg
(n=52)
mg
(n=50)
Patients Achieving Endoscopic Improvement
100%
80%
60%
TOUCHSTONE Ph2
Endoscopic Improvement
Week 8*
A 220; P=0.0023
A 15.4; P=0.0348
40%
34.3%
27.7%
20%
12.3%
0%
Placebo
(n-65)
Ozanimod
Ozanimod 1
0.5 mg
(n=65)
mg
(n=67)
Patients Achieving Endoscopic Improvement
NEW DATA
100%
TRUE NORTH Ph3
Endoscopic Improvement
Week 10
80%
A 15.7; P<0.0001
60%
40%
20%
11.6%
27.3%
0%
Placebo
(n=216)
Ozanimod 1 mg
(n=429)
Definition of Endoscopic Improvement
An endoscopic subscore of ≤1 point
Cross-trial comparisons, not head-to-head studies: no direct comparisons can be m
Oasis study: W.J. Sandborn el al. Gastroenterology 2020;158:550-561
True North study: W.J. Sandborn el al. N Engl J Med 2021;385:1280-91
Touchstone study: W.J. Sandborn el al. N Engl J Med 2016; 374:1754-1762
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