Vera Therapeutics (NASDAQ:VERA) shares rose 13% on Tuesday after the company reported that TRUTAKNA (atacicept-vymj) met all prespecified endpoints in the final efficacy analysis of its ORIGIN 3 trial in adults with primary IgA nephropathy.
The company said the results showed that TRUTAKNA stabilised estimated glomerular filtration rate, or eGFR, and reduced kidney disease progression through two years in patients considered at risk of disease progression.
TRUTAKNA is an FDA-approved inhibitor targeting BAFF and APRIL.
TRUTAKNA Shows Difference in Kidney Function Measure
The final efficacy analysis included 428 patients. At 52 weeks, the mean change in eGFR from baseline was -0.1 mL/min/1.73m² for patients receiving TRUTAKNA, compared with -5.7 mL/min/1.73m² for placebo, representing a treatment difference of 5.6 mL/min/1.73m².
Through 104 weeks, the annualised eGFR slope was -0.6 mL/min/1.73m² per year in the TRUTAKNA group and -5.6 mL/min/1.73m² per year for placebo, a treatment difference of 5.0 mL/min/1.73m² per year.
Vera also reported a 76% reduction in the risk of composite kidney disease progression events through 104 weeks. There were 11 events among patients receiving TRUTAKNA compared with 38 in the placebo group.
No patients in the TRUTAKNA group underwent dialysis for at least 30 days, received a kidney transplant or died through 104 weeks, compared with eight patients in the placebo group.
Safety Rates Generally Comparable With Placebo
Vera said the overall safety profile of TRUTAKNA was generally comparable with placebo.
Rates of overall adverse events and infections were similar between the treatment and placebo groups. The company reported no opportunistic infections or clinically relevant hypogammaglobulinemia.
Vera Plans Supplemental FDA Filing in Fourth Quarter
Vera said more than 350 patient start forms were generated during the first 10 weeks following TRUTAKNA’s accelerated approval.
The company plans to submit a supplemental Biologics License Application to the US Food and Drug Administration in the fourth quarter of 2026 seeking full approval for the treatment.
Vera Therapeutics stock price
