Kiniksa Pharmaceuticals Provides Corporate Update - Seite 2

• Kiniksa today announced that the Phase 2 clinical trial of abiprubart in rheumatoid arthritis met its primary efficacy endpoint, change from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) versus placebo.
  • In Cohorts 1 and 2 (pharmacokinetic (PK)-lead in), multiple doses of abiprubart were well-tolerated and enabled the proof-of-concept portion of the study. Although these cohorts were not powered for DAS28-CRP (Secondary Efficacy Endpoint), the following results were observed:
    • In Cohort 1, in the abiprubart 2 mg/kg subcutaneous (SC) biweekly dosing group (n=6), the mean change from baseline in DAS28-CRP at Week 12 was -3.16 points compared to -1.09 points in pooled placebo recipients (n=4), (Mean Difference = -2.07, p=0.0312).
    • In Cohort 2, in the abiprubart 5 mg/kg SC biweekly dosing group (n=6), the mean change from baseline in DAS28-CRP at Week 12 was -3.44 points compared to pooled placebo recipients (n=4), (Mean Difference = -2.35, p=0.0338).
  • In Cohort 3, in the abiprubart 5 mg/kg SC weekly dosing group (n=27), the Least Squares (LS) mean change [95% confidence interval (CI)] from baseline in DAS28-CRP at Week 12 was -2.21 [-2.62, -1.80] points compared to -1.65 [-2.07, -1.23] points in placebo recipients (n=26), (LS Mean Difference = -0.56, p=0.0487).
  • In Cohort 3, in the abiprubart 5 mg/kg SC biweekly dosing group (n=25), the LS mean change [95% CI] from baseline in DAS28-CRP at Week 12 was -2.00 [-2.43, -1.58] points compared to -1.65 [-2.07, -1.23] points in placebo recipients (n=26), (LS Mean Difference = -0.35, p=0.2140).
  • Abiprubart significantly reduced Rheumatoid Factor (a clinical marker of disease activity and autoantibody pharmacodynamic marker of CD40 target engagement) by over 40% in both Cohort 3 dose levels.
  • Abiprubart was well-tolerated, with no dose-related adverse experiences observed.
• Kiniksa has now completed enrollment in a fourth cohort (Cohort 4) of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Cohort 4 will evaluate a fixed dose level administered as a single subcutaneous injection once monthly. The company expects data from Cohort 4 in the second quarter of 2024.