An experimental medicine from Vera Therapeutics significantly reduced levels of toxic protein in the urine of patients with an autoimmune kidney disease. The Phase 3 study results reported Monday met an intermittent treatment goal and laid down a marker ahead of a competing study readout later this week.
The Vera drug called atacicept lowered proteinuria levels by 46% after nine months compared to 7% lowering in patients given a placebo. The improvement — 42% as calculated using a prespecified statistical model that takes into account baseline factors — will support a regulatory submission to the Food and Drug Administration before the end of the year, Vera said.
The study enrolled 203 patients with IgA nephropathy, or IgAN, a chronic kidney disease caused by the build-up of antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis. Patients in the Vera study were in their 40s with high-risk disease causing kidney deterioration despite the use of other medications.
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