Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — Technical Presentation (June 2024)
13 slides from Kiniksa Pharmaceuticals International's technical presentation, Jun 7, 2024
Slide 1: Efficacy, Safety, and Pharmacokinetics of Anti-CD40 Antibody Abiprubart in Rheumatoid Arthritis
EFFICACY, SAFETY, AND PHARMACOKINETICS OF ANTI-CD40 ANTIBODY ABIPRUBART (KPL-404) IN PATIENTS WITH RHEUMATOID ARTHRITIS: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, 12-WEEK- TREATMENT, PROOF-OF-CONCEPT STUDY Eric Jenkins1, Ingrid Louw2, Attila Balog3, Elsa Van Duuren4, Diane Horowitz5, Janusz Jaworsk
Slide 2: Disclosures
Disclosures Ingrid Louw: consultant for Pfizer, Janssen, Lilly, AbbVie. Elsa Van Duuren: speakers bureau for Pfizer, Aspen, Janssen, Lilly, Adcock-Ingram, Roche, Mundi-Pharma, AbbVie; consultant for Boehringer-Ingelheim, AbbVie, Aspen, Pfizer, Janssen. Diane Horowitz: research support from Pfizer, S
Slide 3: CD40/CD154 Interaction: Essential Immune Pathway for T-Cell Priming and T-Cell Dependent B-Cell Responses
CD40/CD154 Interaction: Essential Immune Pathway for T-Cell Priming and T-Cell Dependent B-Cell Responses • CD40/CD154 interaction is implicated in a range of autoimmune diseases • Abiprubart (KPL-404): • Humanized monoclonal IgG4 antibody • Stabilized/functionally-silent Fc region • Binds to CD40 a
Slide 4: Abiprubart Demonstrated Prolonged TDAR Suppression in Phase 1
Abiprubart Demonstrated Prolonged TDAR Suppression in Phase 1 • Phase 1 SAD study in healthy human volunteers1 • Abiprubart was well tolerated • Dose-dependent duration of full CD40 target engagement • Sustained dose-dependent TDAR suppression with both SC and IV administration • High-concentration
Slide 5: Phase 2 Trial of Abiprubart in Rheumatoid Arthritis
Phase 2 Trial of Abiprubart in Rheumatoid Arthritis Phase 2 Study Objectives: • Evaluate the safety and PK of multiple doses of abiprubart SC in RA patients versus placebo (Cohorts 1 & 2) • Evaluate the efficacy of abiprubart SC versus placebo in RA patients (Cohorts 3 & 4) PHARMACOKINETICS (PK) LEA
Slide 6: Baseline Demographics And Disease Characteristics Balanced Across Treatment Arms
Baseline Demographics And Disease Characteristics Balanced Across Treatment Arms Cohort 31 Cohort 41 Abiprubart Abiprubart Placebo Abiprubart Placebo 5 mg/kg SC qwk 5 mg/kg SC q2wk 400 mg SC q4wk (n=27) (n=25) (n=26) (n=31) (n=20) Baseline Demographics Mean Age, years 58.5 (9.7) 60.0 (10.1) 57.6 (9.
Slide 7: Phase 2 Trial of Abiprubart in RA Met Primary Efficacy Endpoint
Phase 2 Trial of Abiprubart in RA Met Primary Efficacy Endpoint Change from Baseline in DAS28-CRP vs Placebo at Week 12 Cohort 1 & 2 Cohort 3 Cohort 4 DAS28-CRP Mean Change from Baseline1* DAS28-CRP LS Mean Change from Baseline1,2* DAS28-CRP LS Mean Change from Baseline3* Cohort 1: 2 mg/kg SC q2wk C
Slide 8: Pharmacodynamics & Pharmacokinetics: Reductions in Rheumatoid Factor at all SC Dose Intervals
Pharmacodynamics & Pharmacokinetics: Statistically Significant Similar Magnitude Reductions in Rheumatoid Factor at all SC Dose Intervals RF is an anti-Ig Fc autoantibody which not only serves as a disease marker but also provides a mechanism-related PD marker of anti-CD40 target engagement. Abiprub
Slide 9: Pooled Analysis: Abiprubart Significantly Reduced DAS28-CRP Over Time
Pooled Analysis: Abiprubart Significantly Reduced DAS28-CRP Over Time Pooled Cohorts 3 & 4 DAS28-CRP LS Mean Change from Baseline1* LS Mean Difference: -0.52, nominal p=0.010 • Pooled abiprubart (n=83): -2.04 [-2.34, -1.74] • Pooled placebo (n=46): -1.52 [-1.88, -1.16] 1) Modified Intention to Treat
Slide 10: Abiprubart was Well-Tolerated - No Dose-related Adverse Experiences
Abiprubart was Well-Tolerated - No Dose-related Adverse Experiences Cohort 31* Cohort 41* Category2 Abiprubart Abiprubart Placebo Abiprubart Placebo 5 mg/kg SC qwk 5 mg/kg SC q2wk 400mg SC q4wk (n=27) (n=25) (n=26) (n=31) (n=20) Treatment Emergent Adverse Events 44.4 (n=12) 24.0 (n=6) 30.8 (n=8) 25.
Slide 11: Summary and Conclusions
Summary and Conclusions • Phase 2 RA study met its primary efficacy endpoint • In refractory RA patients, abiprubart treatment resulted in a statistically significant reduction in DAS28-CRP at Week 12 compared to placebo in the 5mg/kg SC weekly dosing group. • Comparable activity across weekly, biwe
Slide 12: Impact on Clinical Practice
Impact on Clinical Practice Abiprubart has potential to provide meaningful benefit to patients suffering from a spectrum of autoimmune diseases, including Sjögren’s Disease, a debilitating disease with no current FDA-approved therapies. Phase 2b Sjögren’s Disease Trial Study Design Trial is expected
Slide 13: Acknowledgments
Acknowledgments We thank the patients who participated and acknowledge the other investigators involved in the study. Medical writing support provided by Allison Curtis, PhD, Kiniksa Pharmaceuticals and Pamela Harvey, PhD, Acumen Medical Communications. Funded by Kiniksa Pharmaceuticals.
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