[{"id":"val-ep1","name":"Proteinuria reduction (UPCR) at Week 26","type":"PRIMARY","unit":"%","p_value":"<0.0001","results":[{"ci":"-74.9 to -57.2","arm":"val-pcc","label":"-67.2% reduction","value":-67.2},{"ci":"-8.6 to +15.9","arm":"val-pbo","label":"+2.9% (worsening)","value":2.9}],"timepoint":"Week 26","description":"C3G and IC-MPGN are complement-mediated kidney diseases with no prior approved treatments. Proteinuria (protein leaking into urine) is a key marker of kidney damage. Reducing it by >50% is associated with slowing progression to kidney failure."}]

Pegcetacoplan not associated with more AEs than placebo. No serious infections from encapsulated bacteria. 52-week extension showed durable proteinuria reduction maintained (-67.2% at 52 weeks).

VALIANT is a landmark study - first positive Phase 3 in C3G/IC-MPGN. 67% proteinuria reduction and 71% complete C3 clearance are remarkable. EC approved Jan 2026. This expands Aspaveli beyond PNH into a rare kidney disease with zero alternatives. SOBI bought out 90% of Apellis ex-US royalties for $275M + $25M milestones (July 2025), making this highly profitable for SOBI.

C3G and IC-MPGN are caused by dysregulated complement activation at the C3 level, leading to C3 deposition in the kidney glomeruli. Pegcetacoplan (C3 inhibitor) directly blocks the pathogenic mechanism. Published in NEJM 2025.