Vera Therapeutics announced that its drug, TRUTAKNA™ (atacicept-vymj), met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial for adults with primary IgA nephropathy (IgAN). The results demonstrated a statistically significant stabilization of kidney function and a substantial reduction in the risk of disease progression compared to placebo.
Key Details
- Primary Outcome: The trial successfully showed a placebo-adjusted benefit of 5.6 mL/min/1.73m² in mean estimated glomerular filtration rate (eGFR) change from baseline at 52 weeks (p<0.0001).
- Disease Progression: TRUTAKNA demonstrated a 76% risk reduction in the composite kidney disease progression event through 104 weeks compared to placebo (Hazard Ratio: 0.24, p<0.0001).
- Regulatory Plans: Based on these results, the company plans to submit a supplemental Biologics License Application (sBLA) to the U.S. FDA for full approval in Q4 2026.
- Safety Profile: The drug was reported as well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous results from the ORIGIN program.