(RTTNews) - Vera Therapeutics, Inc. (VERA), Thursday announced data from the ORIGIN Phase 3 trial of atacicept in IgA nephropathy, stating that the study met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36.
The company noted that the participants treated with atacicept achieved a 46 percent reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio, with a statistically significant and clinically meaningful 42 percent reduction in UPCR compared to placebo at week 36.
Atacicept treatment also led to improvements in secondary endpoints as Gd-IgA1 reduced by 68 percent and hematuria resolved in 81 percent of participants with baseline hematuria.
The company expects these findings to support its planned Biologics License Application submission through the Accelerated Approval Program to the U.S. FDA expected in the fourth quarter 2025, with potential PDUFA date in 2026.
Meanwhile, ORIGIN 3 trial continues with two-year results expected in 2027.
Currently, VERA is trading at $24.14, up 0.25 percent on the Nasdaq.
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