[{"id":"dissolve1-ep1","name":"sUA <6 mg/dL for >=80% of Month 6","type":"PRIMARY","unit":"%","results":[{"arm":"nasp-high","label":"51% (high dose)","value":51},{"arm":"nasp-low","label":"43% (low dose)","value":43},{"arm":"nasp-pbo","label":"Placebo: not reported","value":null}],"timepoint":"Month 6","description":"Proportion of patients maintaining serum uric acid below 6 mg/dL for at least 80% of the time during month 6. This is the standard gout regulatory endpoint - keeping uric acid low enough to dissolve the urate crystals that cause joint inflammation and tophi."}]

Phase 3, randomized, double-blind, placebo-controlled (N=112, US-only, 1:1:1). Primary endpoint: sUA <6 mg/dL for >=80% of Month 6. HD (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase): 56% vs 4% placebo (p<0.0001). LD (0.10 mg/kg ImmTOR): 48% vs 4% (p<0.0001). Patients >=50y: HD 65%, LD 47% vs 5%. Mean sUA dropped from 8.4 to 0.2 mg/dL within 1hr of first dose. Weeks 21-24: 95% HD patients flare-free vs 72% placebo. Tophi complete resolution (6-dose completers): HD 49% (p=0.0002), LD 70% (p<0.0001) vs 5% placebo. 24-week extension: 75% of Month-6 responders maintained through Month 12; HD 100% flare-free at weeks 45-48.

Pooled DISSOLVE I+II (N=265 active). Any TEAE: HD 72.4%, LD 70.5%, PBO 63.3%. Most common: gout flare (HD 42.5%, LD 44.3%, PBO 43.3%). Stomatitis: HD 9.2%, LD 3.4%, PBO 0%. Infusion reactions: HD 3.4%, LD 4.5%; all within first 3 infusions, all resolved. Zero IRs in 24-week extension. Treatment-related SAEs: 6 patients (3.4%) — 4 anaphylaxis, 2 serious gout flares. Anti-uricase ADA positive at Month 6: HD 53%, LD 67%; only high-titer ADAs associated with loss of sUA control. 1 unrelated death (MVA) during extension.

DISSOLVE I met primary endpoint. Pooled with DISSOLVE II for BLA submission. PDUFA June 27, 2026. Key question: label breadth and whether FDA requires methotrexate co-therapy (NASP does NOT need it - competitive advantage vs Krystexxa+MTX).

NASP combines pegadricase (pegylated uricase that breaks down uric acid) with nanoencapsulated sirolimus (prevents anti-drug antibody formation that historically limited Krystexxa efficacy). The sirolimus component is the key innovation - it solves the immunogenicity problem.