Expert: Sequential IV infusion of nanoencapsulated sirolimus (NAS, ImmTOR technology) followed by pegadricase (PEGylated uricase). NAS delivers rapamycin to antigen-presenting cells in a tolerogenic context, inducing antigen-specific regulatory T cells that suppress anti-drug antibody (ADA) formation against pegadricase. This overcomes the key limitation of uricase therapy — immunogenicity-driven loss of efficacy.

Everyday: A two-part injection that dissolves uric acid crystals in gout. Part 1 is a tiny nanoparticle "decoy" (sirolimus wrapped in a lipid ball) that teaches the immune system NOT to attack the drug. Part 2 is a uric acid-eating enzyme (uricase) that rapidly breaks down uric acid. The genius is Part 1 — previous uricase drugs failed because the body made antibodies against them. The nanoparticle prevents that.

Targets: []

Primary EP: [{"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 do

Efficacy: 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 s

Safety: 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%

Primary EP: [{"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"

Efficacy: 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%)

Safety: 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%. Tr

NASP - Uncontrolled Gout - FDA PDUFA Decision June 27, 2026

First-in-class tolerogenic uricase for uncontrolled gout. BLA accepted by FDA, PDUFA June 27, 2026. Phase 3 DISSOLVE I+II: pooled response rate 51% (high dose) and 43% (low dose) on primary endpoint (sUA <6 mg/dL for >=80% of month 6). Mechanism: NAS (ImmTOR nanoparticles) induces immune tolerance to prevent anti-drug antibodies against pegadricase (uricase). This solves the key failure mode of Krystexxa (pegloticase), where ~50% of patients develop neutralizing antibodies. Originally developed by Selecta Biosciences. Sobi acquired rights.