Clinical TrialSep 15, 2026, 06:56 AM
Vera Therapeutics: TRUTAKNA Meets All Endpoints in IgAN Trial
AI Summary
Vera Therapeutics announced that TRUTAKNA™ (atacicept-vymj) met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy (IgAN). The trial showed TRUTAKNA stabilized eGFR and prevented kidney disease progression through two years. The company plans to submit a supplemental BLA to the FDA in Q4 2026 for full approval. The drug also showed strong commercial launch momentum with over 350 patient start forms generated in the first ten weeks.
Key Highlights
- TRUTAKNA met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial for IgA nephropathy.
- Mean eGFR change from baseline at 52 weeks was -0.1 mL/min/1.73m2 for TRUTAKNA vs -5.7 for placebo (p<0.0001).
- Annualized eGFR slope through 104 weeks was -0.6 mL/min/1.73m2/year for TRUTAKNA vs -5.6 for placebo (p<0.0001).
- Composite kidney disease progression event through 104 weeks occurred in 11 patients on TRUTAKNA vs 38 on placebo (76% risk reduction, p<0.0001).
- No patients on TRUTAKNA experienced dialysis, transplant, or death through 104 weeks, vs 8 on placebo.
- TRUTAKNA demonstrated statistically significant reductions in proteinuria, galactose-deficient IgA1, and hematuria.
- TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo.
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