Vera Therapeutics Inc VERA announced 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 show 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.
After completing the 36-week Phase 2b ORIGIN trial, all participants were eligible to receive atacicept 150 mg in the OLE. Of the 116 randomized participants, 106 completed 72 weeks.
Participants treated with atacicept for 72 weeks demonstrated a 62% reduction in Gd-IgA1, a reduction in the percentage of participants with hematuria to 19%, and a 48% reduction in UPCR in the per-protocol (PP) analysis.
Participants had consistent and stable eGFR with 0 mL/min/1.73m2 change from baseline at 72 weeks. It has been shown that eGFR declines by approximately 1 mL/min/1.73m2 per year in the general population.
Participants who switched from placebo to atacicept demonstrated similar outcomes across each of the key indicators of IgAN as compared to participants randomized initially to atacicept during the first 36 weeks of the trial, including a 59% reduction in Gd-IgA1, a reduction in the percentage of participants with hematuria to 41%, and a 47% reduction in UPCR in the PP analysis.
In addition, eGFR stabilization was observed in participants who switched from placebo to atacicept with a -3.2 mL/min/1.73m2 change from baseline at 72 weeks compared to -4.9 mL/min/1.73m2 at 36 weeks.
Safety data in the OLE were consistent with the randomized period and indicated that atacicept was generally well-tolerated.
Price Action: VERA shares are up 50.3% at $25.58 on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.