Kiniksa Pharmaceuticals Announces Development Indication for Abiprubart - Seite 2

Abiprubart Phase 2 Rheumatoid Arthritis Data
The Phase 2 rheumatoid arthritis trial uses a randomized, double-blind, placebo-controlled design to evaluate pharmacokinetics (PK), safety, and efficacy of chronic SC administration of abiprubart and to provide optionality to evaluate abiprubart across a range of autoimmune diseases. The trial enrolled patients with active rheumatoid arthritis who had an inadequate response or were intolerant to a Janus kinase inhibitor (JAKi) or at least one biologic disease-modifying anti-rheumatic drug (bDMARD).

Following previously reported topline data, Kiniksa today announced final data from the first three cohorts of the clinical trial:

• In Cohorts 1 and 2, multiple doses of abiprubart were well-tolerated and enabled the proof-of-concept portion of the study.
• In the Cohort 3 abiprubart 5 mg/kg SC weekly dose group (n=27), the Least Squares (LS) mean change [95% confidence interval (CI)] from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12 was -2.17 [-2.60, -1.74] points, compared to -1.61 [-2.04, -1.17] points in placebo recipients (n=26), (LS Mean Difference = -0.57, p=0.0470).
• In the Cohort 3 abiprubart 5 mg/kg SC biweekly dose group (n=25), the LS mean change [95% CI] from baseline in DAS28-CRP at Week 12 was -1.96 [-2.40, -1.52] points, compared to -1.61 [-2.04, -1.17] points in placebo recipients (n=26), (LS Mean Difference = -0.36, p=0.2124).
• There was a statistically significant reduction of over 40% in Rheumatoid Factor, a clinical marker of disease activity and an autoantibody pharmacodynamic marker of CD40 target engagement, in both Cohort 3 abiprubart dose groups (p<0.0001).
• Abiprubart was well-tolerated, with no dose-related adverse experiences observed.
  

Today, Kiniksa announced topline data from the fourth cohort of the clinical trial:

• In the Cohort 4 abiprubart 400 mg SC monthly dose group (n=31), the LS mean change [95% CI] from baseline in DAS28-CRP at Week 12 was -1.87 [-2.54, -1.21] points, compared to -1.30 [-1.98, -0.62] points in placebo recipients (n=20), (LS Mean Difference = -0.58, p=0.109).
• There was a statistically significant reduction of approximately 40% in Rheumatoid Factor in the abiprubart group (p=0.0003).
• As in the first three cohorts, abiprubart was well-tolerated, and no dose-related adverse experiences were observed.