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REDUCE-2 PHASE3 ACTIVE n=750
Drug: Pozdeutinurad · SOBI
Study Design
Design12-month, randomized, double-blind, placebo-controlled
Randomization1:1:1
BlindingDouble-blind
Enrollment750
Duration52 weeks
Treatment Arms
Pozdeutinurad 75 mg 75 mg oral once daily n=250
Pozdeutinurad 50 mg 50 mg oral once daily n=250
Placebo Placebo oral once daily n=250
Primary Endpoints
[{"id":"red2-ep1","name":"sUA <6 mg/dL at Month 6","type":"PRIMARY","unit":"%","results":[],"timepoint":"Month 6","description":"Proportion achieving serum uric acid below 6 mg/dL at 6 months. Longer timepoint than Phase 2b (12 weeks) increases confidence in durability."}]
Assessment
REDUCE-2 is THE catalyst for SOBI in 2026. Positive data validates $1.5B deal, positions SOBI as dominant gout franchise. Negative data = significant stock de-rating, $950M upfront questioned. Phase 2b showed 89% sUA <6 at 75mg (12 weeks); key question is whether 6-month data in larger population replicates. Fully enrolled Q1 2025.
Background & Context
Second of two pivotal Phase 3 trials for regulatory filing. First to complete enrollment (Q1 2025), data expected Q2 2026.
Data from Supabase · Updated 2026-03-24