Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — ACG 2024 Annual Scientific Meeting
12 slides from Ironwood Pharmaceuticals's conference presentation, Oct 29, 2024
Slide 1: Phase 3 STARS Trial of Apraglutide: Subgroup Analyses in SBS-IF
Plenary Session 2A – Small Intestine / Functional / Liver Presentation 19 Phase 3, Double-Blind, Randomized STARS Trial of Apraglutide Once Weekly in Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF): Subgroup Analyses by Baseline Demographics and SBS Disease Characteristics Kishore
Slide 2: Introduction
2 Introduction • SBS-IF is a chronic malabsorptive condition requiring parenteral support1 Endogenous GLP-2 • SBS-IF is anatomically heterogeneous based on Enterocytes remnant bowel anatomy (stoma or colon-in-continuity)1 Goblet cells • Response to treatment can also vary due to:1 Villus L-cells − E
Slide 3: STARS Study Design: Efficacy and Safety of Apraglutide in Adult Patients With SBS-IF
3 STARS Study Design: Efficacy and Safety of Apraglutide in Adult Patients With SBS-IF A pivotal, Phase 3, double-blind, placebo-controlled trial PRIM ARY ENDPOINT Global study • 68 centers in 18 countries 2:1 KEY SECONDARY KEY SECONDARY Two arms (stratified by randomization ENDPOINTS ENDPOINTS stom
Slide 4: Inclusion & Exclusion Criteria
4 Inclusion & Exclusion Criteria Key Inclusion Criteria Key Exclusion Criteria • Receiving PS after surgical resection of the small • Major abdominal surgery within last 6 months intestine with <200 cm from duodeno-jejunal flexure, • Acute cholecystitis, biliary obstruction, or IBD with either: • Ra
Slide 5: Primary & Key Secondary Endpoints
5 Primary & Key Secondary Endpoints Overall population Primary • Relative change from baseline in weekly PS volume at Week 24 Endpoint Overall population Stoma CIC Key Secondary Endpoints • Additional ≥1 day/week off PS • Relative change from • Additional ≥1 day/week off PS at Week 24 baseline in we
Slide 6: Subgroup Analyses: Primary Endpoint by Baseline Demographics and SBS Disease Characteristics
Subgroup Analyses Primary Endpoint by Baseline Demographics and SBS Disease Characteristics Subgroups defined per protocol By baseline demographics By baseline SBS disease characteristics • Gender (M/F) • Body weight (< 50 or ≥ 50 kg) • Age (< or ≥ median; < 65 or ≥ 65 years old) • PS volume (< 12 o
Slide 7: Patient Disposition
7 Patient Disposition Screened N=216 Randomized N=164 Apraglutide Placebo Discontinued prematurely from treatment (n=110) (n=53) n=8 (4.9%) n n Dosed N=163 Reasons for Apraglutide Placebo Stoma (n=80) 54 26 treatment (n=110) (n=53) CIC (n=83) 56 27 discontinuation n (%) n (%) Lost to follow-up 0 0 N
Slide 8: Baseline Demographics and SBS Disease Characteristics
8 Baseline Demographics and SBS Disease Characteristics Apraglutide Placebo Parameter (n=110) (n=53) Baseline demographics Gender (n, %) Male 44 (40.0) 27 (50.9) Age (years; mean [SD]) 51.1 (14.2) 52.3 (16.0) Region (n, %) US 21 (19.1) 7 (13.2) EU + UK 75 (68.2) 37 (69.8) ROW 14 (12.7) 9 (17.0) Race
Slide 9: Primary Endpoint Met: Greater Relative Reduction in Weekly PS Volume at Week 24
9 Primary Endpoint Met (Overall Population): Significantly Greater Relative Reduction in Weekly PS Volume at Week 24 Relative (%) Weekly PS Volume Reduction -12.5% from Baseline P=0.001 -25.5% Apraglutide (n=110) Placebo (n=53) Apraglutide treatment effect observed at Week 8 and onward *P<0.05; ** P
Slide 10: Consistent Apraglutide Effects Across Baseline Demographics
Consistent Apraglutide Effects Across Baseline Demographics Subgroup analyses of the primary endpoint relative change in PS at week 24 by baseline demographics (full analysis set) n LS-means (%) Adjusted mean difference Difference Subgroup APRA PBO APRA PBO (APRA - PBO)* (95% CI) p† Gender Female 66
Slide 11: Consistent Apraglutide Effects Across Baseline SBS Disease Characteristics
Consistent Apraglutide Effects Across Baseline SBS Disease Characteristics Subgroup analyses of the primary endpoint relative change in PS at week 24 by baseline SBS disease characteristics (full analysis set) n LS-means (%) Adjusted mean difference Difference Subgroup APRA PBO APRA PBO (APRA - PBO)
Slide 12: Summary
Summary • Apraglutide is the first once-weekly GLP-2 analog to show efficacy in a Phase 3 trial in patients with SBS-IF − As previously reported, the primary endpoint was met at Week 24, with a significantly larger reduction in weekly PS volume from baseline with apraglutide vs placebo Subgroup anal
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