Vera reports TRUTAKNA kidney trial data

• Vera Therapeutics reported final Phase 3 ORIGIN 3 results for TRUTAKNA in primary IgA nephropathy.
• The treatment reduced kidney disease progression events by 76% compared with placebo over 104 weeks.
• Vera plans to submit a supplemental BLA for full FDA approval in Q4 2026.

Vera Therapeutics (NASDAQ:VERA) reported final Phase 3 ORIGIN 3 results showing TRUTAKNA (atacicept-vymj) stabilized kidney function and reduced disease progression over two years in adults with primary IgA nephropathy at risk of progression.

The trial showed mean eGFR change of -0.1 mL/min/1.73m² with TRUTAKNA compared with -5.7 mL/min/1.73m² with placebo through 52 weeks, representing a placebo-adjusted difference of 5.6 (p<0.0001).

Through 104 weeks, annualized eGFR decline was -0.6 mL/min/1.73m² per year with TRUTAKNA compared with -5.6 with placebo, while composite kidney disease progression events occurred in 11 TRUTAKNA patients versus 38 placebo patients.

Vera Therapeutics said TRUTAKNA met all prespecified endpoints, including reductions in proteinuria, Gd-IgA1, and hematuria, and reported a safety profile generally comparable with placebo.

Vera Therapeutics develops treatments for immune-mediated diseases, including kidney disorders such as IgA nephropathy.

The company reported more than 350 patient start forms within the first 10 weeks after accelerated approval and plans to submit a supplemental Biologics License Application for full FDA approval in the fourth quarter of 2026.