Pozdeutinurad Phase 2b PHASE2 COMPLETED n=140
Drug: Pozdeutinurad · SOBI
Study Design
DesignRandomized, double-blind, placebo-controlled, multicenter
BlindingDouble-blind
Enrollment140
Duration12 weeks
Treatment Arms
Pozdeutinurad 75 mg 75 mg oral once daily n=47
Pozdeutinurad 50 mg 50 mg oral once daily n=47
Placebo Placebo oral once daily n=46
Primary Endpoints
[{"id":"pozd2b-ep1","name":"sUA <6 mg/dL at 12 weeks","type":"PRIMARY","unit":"%","results":[{"arm":"pozd-75","label":"89% (75 mg)","value":89},{"arm":"pozd-50","label":"78% (50 mg)","value":78},{"arm":"pozd-pbo","label":"0% (placebo)","value":0}],"timepoint":"Week 12","description":"Proportion achieving serum uric acid below 6 mg/dL - the standard target in gout treatment. Below 6 mg/dL, urate crystals start dissolving and gout flares decrease over time."}]
Safety Results
No serious adverse events in pozdeutinurad-treated patients. Most common AEs (mild-moderate): diarrhea, headache, upper respiratory infection. No elevation of serum creatinine (key differentiator vs lesinurad, prior URAT1 inhibitor withdrawn for kidney toxicity). No clinically significant hepatotoxicity with monotherapy.
Assessment
INVESTMENT CRITICAL: This Phase 2b data (89% sUA <6 at 75mg) is the basis for SOBI paying $1.5B for Arthrosi. If REDUCE Phase 3 results replicate this, pozdeutinurad could be a multi-billion dollar franchise. The 0% placebo rate shows gout patients truly need ULT therapy. Key risks: (1) Phase 3 uses 6-month endpoint vs 12-week Phase 2b, (2) larger/broader population may dilute response, (3) CV safety monitoring (historical URAT1 class concern).
Background & Context
Next-generation URAT1 inhibitor (uricosuric). Blocks uric acid reabsorption in the kidney, increasing urinary excretion. Unlike lesinurad (withdrawn for renal toxicity), pozdeutinurad has shown no kidney safety signal.
Data from Supabase · Updated 2026-03-24