Shots:
- The P-II (WILLOW) basket trial assessed enpatoran (25, 50 &100mg, BID, PO) vs PBO + SoC in 2 Arms, where Arm 1 has SLE & CLE pts with active lupus rash & Arm 2 has active SLE pts. Discussions with health authorities on a global P-III program are underway
- Arm 1 met its 1EP, showing dose-response & improved CLASI-A at Wk. 16, with ~91.3% vs 38.5% achieving CLASI-50 & ~60.9% vs 11.5% reaching CLASI-70 at Wk. 24. It also reduced interferon gene signatures by Wk. 2, sustained through Wk. 24, confirming TLR7/8 involvement in CLE; data to be shared at LUPUS 2025
- Arm 2 did not meet its 1EP of dose-response but showed favorable efficacy in prespecified subgroups; full results to be shared at EULAR 2025
Ref: Businesswire| Image: MERCK | Press Release
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