Pharma Update
RG6179: Novel anti-IL-6 mAb in UME and DME
Two identical Ph III studies in UME initiated Q1 2023
Ph III (Sandcat/Meerkat) trials in UME
Roche
D1
W4 W8 W12 W16 W20
W48
MEERKAT SANDCAT
Adult patients with
Anti-IL6 0.25mg Q4W for
Anti-IL6 0.25mg PRN
4 weeks
UME
n=225 per study
n=450 total
R
1:1:1
Anti-IL6 1.0mg Q4W for
4 weeks
Off-treatment
Anti-IL6 1.0mg PRN
Sham Q4W for 4 weeks
Sham
Primary endpoint
Durability endpoints
Study completion
Based on the Ph I (DOVETAIL) findings, and supported by PK/PD results, a Ph III study program investigating anti-IL-6 in UME (SANDCAT, MEERKAT) was initiated
with FPI in Q1 2023 and data expected 2025
Primary endpoint: Proportion of patients with ≥15 letters BCVA gain from baseline at week 16
.
Ph II studies in DME (BARDENAS, ALLUVIUM) also ongoing
PK/PD-Pharmacokinetics/Pharmacodynamics; UME-Uveitic macular edema; DME=Diabetic macular edema; PRN=Pro re nata; BCVA-Best-corrected visual acuity; Q4W-Every 4 weeks; IL-6-Interleukin-6; W=Week
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