[{"id":"dissolve2-ep1","name":"sUA <6 mg/dL for >=80% of Month 6","type":"PRIMARY","unit":"%","results":[{"arm":"nasp2-high","label":"51% pooled (DISSOLVE I+II)","value":51},{"arm":"nasp2-low","label":"43% pooled (DISSOLVE I+II)","value":43}],"timepoint":"Month 6","description":"Confirmatory trial replicating DISSOLVE I primary endpoint. Same standard gout endpoint."}]

Phase 3, randomized, double-blind, placebo-controlled (N=153, global US+Eastern Europe, 1:1:1). Primary endpoint: sUA <6 mg/dL for >=80% of Month 6. HD: 47% vs 12% placebo (p=0.0002). LD: 41% vs 12% (p=0.0015). Patients >=50y: HD 48%, LD 45% vs 14%. Higher placebo response (12%) than DISSOLVE I (4%), likely reflecting regional differences. Ex-US subgroup: HD 45%, LD 36% vs 15% placebo. Pooled sUA reduction: -88% HD, -94% LD from baseline ~8.5 mg/dL.

Safety consistent with DISSOLVE I (pooled data reported). TEAEs: HD 72.4%, LD 70.5%, PBO 63.3%. Gout flare ~43% all arms. Stomatitis: HD 9.2%, LD 3.4%, PBO 0%. Infusion reactions: HD 3.4%, LD 4.5%. Treatment-related SAEs (pooled): 6 patients (3.4%) including 4 anaphylaxis, 2 serious gout flares. Anti-uricase ADA+: HD 53%, LD 67%. No new safety signals vs DISSOLVE I.

Met primary endpoint. Pooled with DISSOLVE I for BLA. PDUFA June 27, 2026.

Confirmatory Phase 3 for BLA filing