On Saturday, Vera Therapeutics Inc. (NASDAQ:VERA) released data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN), which showed stabilized kidney function through 96 weeks of long-term follow-up.
These data were presented in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024 and published in a manuscript in the Journal of the American Society of Nephrology.
Over 96 weeks, participants treated with atacicept demonstrated a -66% reduction in galactose-deficient IgA1 (Gd-IgA1), resolution of hematuria in 75% of participants, a -52% reduction in proteinuria, and a mean annualized estimated glomerular filtration rate (eGFR) slope of -0.6 mL/min/1.73m2/year.
The cumulative generally favorable safety profile of atacicept remained consistent with that observed during the randomized period, with a 90% completion rate of atacicept treatment.
The company says these data support the potential for atacicept to offer long-term, comprehensive IgAN disease modification and provide further confidence in the ongoing pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN.
The company plans to initiate an ORIGIN Extend study in the fourth quarter of 2024, which will provide ORIGIN participants with extended access to atacicept before its commercial availability.
The ORIGIN 3 trial is on track to announce topline results in the second quarter of 2025, with planned FDA marketing application submission later in the year.
Earlier this year, Vera Therapeutics revealed 72-week data from the open-label extension (OLE) period of its Phase 2b ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN).
Data from the OLE showed the consistent and sustained reductions of serum galactose-deficient IgA1 (Gd-lgA1), hematuria, and urine protein to creatinine ratio (UPCR), as well as the stability of eGFR over 72 weeks in participants with IgAN.
Price Action: VERA stock is up 12.2% at $46.12 at last check Monday.
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