Ose Immunotherapeutics Sa · EURONEXT:OSE
Ose Immunotherapeutics Sa — ECCO'25 Congress (February 2025)
14 slides from Ose Immunotherapeutics Sa's conference presentation, February 2025
Slide 1: Lusvertikimab, a first-in-class IL7 receptor antagonist, in ulcerative colitis: CoTikiS phase II
Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe ulcerative colitis: results of a multicenter, randomized, placebo-controlled phase II study (CoTikiS) Bourreille A1, Kierkus J2, Corallo F3 and Reinisch W4 on behalf of the CoTikiS study group 1 Nantes University, Institu
Slide 2: Conflict of Interest
Conflict of Interest • A. Bourreille declares conflicts of interest with AbbVie, AlorIS pharma, BMS, BioMadvanced, Celltrion, Ferring, Galapagos, Gilead, MSD, Mauna Kea Technologies, Medtronic, OSE Immunotherapeutics, Janssen, Lilly, Pfizer, Roche, Takeda, Tillotts, Valneva • A. Kierkus declares con
Slide 3: Background
Background • IL-7 is mainly produced by epithelial and stromal cells • IL-7R is expressed on T Lymphocytes, with the exception of Tregs • IL-7 is a crucial survival and expansion factor for CD4+ TEM lymphocytes and innate lymphoid cells1 • IL-7R blockade results in reduced human T cell homing to t
Slide 4: Design
Design Patients with a moderate to severe active UC defined by a Modified Mayo Score (MMS) between 4 and 9 (MES ≥ 2, RB ≥ 1, SF ≥ 1) who had failed or were intolerant to corticosteroids, IS, anti-TNFs, vedolizumab or ustekinumab W0 W10 W34 Lusvertikimab 450mg IV week 0, 2 and 6 R Open label Extensio
Slide 5: Methods
Methods • Efficacy analyses were performed using the FAS population • Safety and adverse events were assessed in all patients who received any amount of the study drug • Sample sizes of 44 per group were expected to achieve 85% power to reject the null hypothesis of equal means between placebo and L
Slide 6: Patient Disposition
Patient Disposition Screened N=211 Randomized N=136 Placebo L 450 mga L 850 mg N=49 N=36 N=51 Diagnosis Diagnosis modification modification Crohn’s d.: n=1 Crohn’s d.: n=1 Placebo L 450 mg L 850 mg N=49 N=35 N=50 alusvertikimab 450mg was dropped at a prespecified futility analysis after 58 patients;
Slide 7: Patients demographics and baseline disease characteristics
Patients demographics and baseline disease characteristics Placebo Lusvertikimaba Lusvertikimab (n=49) 450 mg (n=35) 850 mg (n=50) Age: mean (SD) 42.7 (15.9) 38.8 (10.5) 42.5 (15.1) Sex: Male, n (%) 28 (57.1%) 22 (62.9%) 27 (54.0%) Never Smoker, n (%) 39 (79.6%) 25 (71.4%) 43 (86.0%) UC Duration (Ye
Slide 8: Changes in MMS (primary endpoint) and Clinical Remission rate at w10
Changes in MMS (primary endpoint) and Clinical Remission rate at w10 Primary endpoint: changes in MMS at w10 Clinical Remission rate at w10 50 % of Patients with Clinical Remisssion Placebo 450 850 450/850 (n=49) (n=35) (n=50) (n=85) Δ 11.8% p= 0.066 0 40 Δ 8.6% p= 0.161 mean change from baseline 30
Slide 9: Secondary endpoints: Endoscopic Improvement and Endoscopic Remission rates at w10
Secondary endpoints: Endoscopic Improvement and Endoscopic Remission rates at w10 Changes in UCEIS at w10 Endoscopic Remission at w10 Placebo 450 850 450/850 p= 0.120 Δ 12.4% (n=49) (n=35) (n=50) (n=85) 50 0.0 % of Patients with Endoscopic Remisssion Δ 6.8% p= 0.385 UCEIS mean change from baseline Δ
Slide 10: Secondary endpoints: Histological Improvement and HEMI rates at w10
Secondary endpoints: Histological Improvement and Histo- endoscopic Mucosal Improvement (HEMI) rates at w10 Histological Improvement at w10 Histo-Endoscopic Mucosal Improvement at w10 Δ 27.0%; p<0.01 Δ 21.0%; p=0.02 Δ 14.4% ; p = 0.05 Δ 35.2%; p<0.01 Δ 6.8% 50 40 45% Δ 24.8%; p<0.01 % of Patients wi
Slide 11: Secondary endpoints: F-calprotectin changes from baseline at w10
Secondary endpoints: F-calprotectin changes from baseline at w10 F-calprotectin changes from baseline 250 189 W10 mean change from baseline Placebo 450 850 450/850 Fecal Calprotectin (µg/g) (n=49) (n=35) (n=50) (n=85) 0 -250 -500 -635 -750 -716 -830 Δ -1018 -1000 p=0.009 Δ -824 p=0.018 Δ -904 p=0.00
Slide 12: Safety
Safety L450 mg L850 mg Placebo Total (N=36) (N=51) (N=49) (N=136) N(%) [E] N(%) [E] N(%) [E] N(%) [E] At least one TEAE 17 (47.2%) [33] 20 (39.2%) [42] 16 (32.7%) [29] 53 (39.0%) [104] Lymphopenia 4 (11.1%) [5] 2 (3.9%) [2] 1 (2.0%) [1] 7 (5.1%) [8] Anaemia 1 (2.8%) [1] 0 2 (4.1%) [2] 3 (2.2%) [3] U
Slide 13: Conclusions
Conclusions • Lusvertikimab demonstrated clinical, endoscopic, histological and biological efficacy vs placebo at week 10 at both 450 and 850mg doses • Lusvertikimab was well tolerated with transient lymphopenia occurring in 6.9% and lymphopenia <0.5*109/L in 4.6% of patients, without a higher rate
Slide 14: Acknowledgements
Acknowledgements Investigators Patients and their families Jaroslaw Kierkus Olena Datsenko Yury Shvarts Tetiana Lohdanidi Data Safety Monitoring Board Petar Svorcan Liubov Mykolajivna Savitska Walter Reinisch Elena Mikhailova Oleksiy Vyacheslavovych Leoshyk Martine Jasson David Jugheli Stefan Baydan
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