Vera Therapeutics Inc. (VERA) shares had a jittery Tuesday, initially spiking higher before turning lower, then recovering, as investors chewed over fresh data from the company's ORIGIN 3 trial.
The headline: Trutakna (atacicept-vymj) met all prespecified endpoints in the final efficacy analysis in adults with primary IgA nephropathy, a kidney disease where the immune system quietly damages the filters that clean your blood.
The final analysis, covering 428 patients, showed a significant reduction in the risk of composite kidney disease progression, what the company calls true stabilization of estimated glomerular filtration rate (eGFR), and a favorable safety profile through two years.
For the uninitiated, eGFR is a calculated blood test score that shows how well the kidneys filter waste from your blood. When it falls, kidneys are failing. When it holds steady, that's the whole ballgame.
eGFR Stabilization and Long-Term Outcomes
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.
Through 104 weeks, the annualized 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. In plain English: the treatment group's kidney function basically flatlined in the good way, while placebo patients kept declining.
Reduction In Kidney Disease Progression Risk
Vera also reported a 76% reduction in the risk of composite kidney disease progression events through 104 weeks. The data reported 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.
“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, principal investigator for the ORIGIN 3 trial.
VERA Price Action: Vera Therapeutics shares were up 2.09% at $34.76 at the time of publication on Tuesday, according to market data.