Vera Therapeutics drug meets all endpoints in two-year IgAN trial

Vera Therapeutics (Nasdaq: VERA) announced that its drug TRUTAKNA (atacicept-vymj) met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy (IgAN) at risk for disease progression, according to a company press release.

The analysis of 428 patients showed a mean eGFR change from baseline of -0.1 in the TRUTAKNA group versus -5.7 in the placebo group at 52 weeks, a treatment effect of 5.6 (p<0.0001). Over 104 weeks, the annualized eGFR slope was -0.6 for TRUTAKNA versus -5.6 for placebo, a treatment effect of 5.0 (p<0.0001).

For composite kidney disease progression events through 104 weeks, 11 events were recorded in the TRUTAKNA group compared with 38 in the placebo group, representing a hazard ratio of 0.24 and a 76% risk reduction (p<0.0001). No patients in the TRUTAKNA group required dialysis for 30 or more days, received a transplant, or died, compared with eight patients in the placebo group.

TRUTAKNA also achieved statistically significant reductions in proteinuria, galactose-deficient IgA1, and hematuria. Rates of adverse events and infections were similar between the two groups, with no opportunistic infections or clinically relevant hypogammaglobulinemia reported.

"Prevention of kidney failure or kidney-related death is the ultimate goal. We now have evidence suggesting that TRUTAKNA may help patients avoid dialysis, transplantation, or kidney-related death over the long term," said Richard Lafayette, M.D., a principal investigator for ORIGIN 3 and director of the Glomerular Disease Center at Stanford University Medical Center.

Vera Therapeutics said it plans to submit a supplemental Biologics License Application to the U.S. Food and Drug Administration for full approval in the fourth quarter of 2026. TRUTAKNA currently holds accelerated FDA approval based on reduction of proteinuria.

The company also reported that more than 350 patient start forms were generated in the first ten weeks following the commercial launch of TRUTAKNA.

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