Roche Holding Ltd · SIX:RO

Roche — ACG 2024 (American College of Gastroenterology Annual Scientific Meeting)

12 slides from Roche's conference presentation, Oct 25, 2024

  1. Slide 1: TUSCANY-2: A Dose-Ranging Phase IIb Study of RO7790121 in Ulcerative Colitis

    TUSCANY-2: A Dose-Ranging Phase IIb Study Evaluating Efficacy and Safety of RO7790121, an Antibody Against Tumor Necrosis Factor-like Ligand 1A (Anti-TL1A) in Adults with Moderately to Severely Active Ulcerative Colitis Silvio Danese,1 Jessica R. Allegretti,2 Stefan Schreiber,3 Laurent Peyrin-Biroul

  2. Slide 2: Introduction

    Introduction TLR stimulation TCR Stimulation Inflammatory Stimuli Immune complexes TNFα Monocytes IL-1β Intestinal bacteria Lymphocytes Dendritic cells Endothelial cells • There is a need for continued evolution and Constitutive expression novel therapeutic approaches in IBD1–3 Macrophages TL1A • TL

  3. Slide 3: The phase 2b TUSCANY-2 study aimed to evaluate efficacy and safety of RO7790121

    The phase 2b TUSCANY-2 study aimed to evaluate the efficacy and safety of RO7790121 in adult patients with moderately to severely active UC October 25-30, Philadelphia, PA UC, ulcerative colitis.

  4. Slide 4: TUSCANY-2: a randomized, double-blind, placebo-controlled, dose-ranging, phase 2b study

    TUSCANY-2: a randomized, double-blind, placebo-controlled, treat-through, dose-ranging, phase 2b study Induction period* Maintenance period† Key eligibility criteria RO7790121 50 mg, SC, Q4W (N=12) Placebo, SC, Q4W (n=45) RO7790121 150 mg, SC, Q4W (N=14) • Patients aged 18–75 years RO7790121 450 mg,

  5. Slide 5: Baseline characteristics were generally similar between induction treatment arms

    Baseline characteristics were generally similar between induction treatment arms Placebo 50 mg 150 mg 450 mg Overall (n=45) (n=47) (n=62) (n=91) (N=245) Age (yr), mean (SD) 39.9 (12.9) 37.8 (13.9) 42.2 (13.0) 41.6 (13.8) 40.7 (13.5) Sex, female, n (%) 21 (46.7) 19 (40.4) 23 (37.1) 36 (39.6) 99 (40.4

  6. Slide 6: Higher proportions experienced clinical remission vs placebo at Week 14

    Higher proportions of patient across all RO7790121 doses experienced clinical remission vs placebo at Week 14 Clinical remission by tMS Clinical remission by mMS 80 Δ=20.2 (3.2, 31.3) Δ=12.2 (–0.6, 22.9) Proportion of participants (90% CI) Δ=23.4 (6.2, 36.3) Placebo 60 Δ=11.7 (–1.7, 24.1) 50 mg Δ=18

  7. Slide 7: Remission rates sustained through Week 56

    Remission rates at Week 14 were sustained through Week 56 in participants treated with RO7790121 Clinical remission by tMS* Clinical remission by mMS* 80 80 50 mg 150 mg Proportion of participants (90% CI) Proportion of participants (90% CI) 450 mg 60 60 38.5% 39.3% 37.9% 34.6% 35.7% 31% 27.6% 30.4%

  8. Slide 8: Endoscopic improvement greater with RO7790121 vs placebo, sustained up to Week 56

    Rates of endoscopic improvement at Week 14 were greater in participants receiving RO7790121 vs placebo, sustained up to Week 56 Endoscopic improvement at Week 14 Endoscopic improvement at Weeks 14 and 56* Placebo All participants vs placebo Participants receiving the same dose of RO7790121 50 mg dur

  9. Slide 9: Substantial decreases in fecal calprotectin across all RO7790121 doses

    Substantial decreases in fecal calprotectin were observed between baseline and Week 12 across all RO7790121 doses vs placebo Mean fecal calprotectin fold change Mean fecal calprotectin fold change (μg/g) at (μg/g) at weeks 0, 4, 8 and 12 weeks 0, 4, 8, and 12 (combined RO7790121 doses) Mean fold cha

  10. Slide 10: Safety results

    Safety results Induction period* Placebo 50 mg 150 mg 450 mg Total (N=45) (N=47) (N=62) (N=91) (N=245) Participants with any adverse event, n (%) 25 (55.6) 16 (34.0) 28 (45.2) 48 (52.7) 117 (47.8) Participants with serious adverse events 4 (8.9) 3 (6.4) 0 (0.0) 3 (3.3) 10 (4.1) Participants disconti

  11. Slide 11: Conclusions

    Conclusions • Treatment with RO7790121 resulted in notable improvements in efficacy endpoints • Clinically meaningful improvements in clinical remission by tMS, mMS, as well as endoscopic improvements were seen across all RO7790121 doses versus placebo at week 14, and these were sustained up to week

  12. Slide 12: Acknowledgments

    Acknowledgments We, as authors, would like to thank: • Participants, their families, and their caregivers for their participation in TUSCANY-2 • Study investigators and their team members at each site for their support during the trial conduct • Funding: Pfizer, Inc, Roivant Sciences, Ltd, and F. Ho

Roche Holding — ACG 2024 (American College of Gastroenterology Annual Scientific Meeting) on 6ix