Business
Vera Therapeutics Presents Phase 2a Data Showing Atacicept Reduces Serum Gd-IgA1 in Patients with IgA Nephropathy at the American Society of Nephrology Kidney Week 2021
Phase 2a JANUS clinical trial showed atacicept administered subcutaneously once weekly demonstrated a durable and substantial reduction in serum
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"Phase 2a JANUS clinical trial showed atacicept administered subcutaneously once weekly demonstrated a durable and substantial reduction in serum galactose-deficient IgA1 (Gd-IgA1) in a dose-dependent manner up to 72 weeksNew quartile-based analysis of JANUS results showed atacicept 75mg reduced serum Gd-IgA1 to the lowest risk quartiles Gd-IgA1 plays a central role in IgAN pathogenesis and renal survival has been shown to deteriorate by the quartile of serum Gd-IgA1 level SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients’ lives, today presented clinical data for the Company’s lead product candidate, atacicept, from the Phase 2a JANUS clinical trial in patients with IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week 2021 Annual Meeting held virtually November 4-7, 2021. “Research has shown that Gd-IgA1 plays a significant role in the pathogenesis of IgAN, whereby higher levels of Gd-IgA1 are associated with increased risk of end-stage renal disease or death. These data show the potential of atacicept to reduce Gd-IgA1 levels and therefore potentially mitigate the poor prognosis of patients with IgAN based on Gd-IgA1,” said Celia Lin, MD, Chief Medical Officer at Vera Therapeutics. “We look forward to announcing the results from the ongoing Ph2b ORIGIN trial evaluating atacicept up to 150mg in IgAN patients to help determine how these robust reductions in Gd-IgA1 translate to measures of renal function, including proteinuria and glomerular filtration rate.” In the Phase 2a randomized, placebo-controlled JANUS trial in 16 IgAN patients, serum galactose-deficient IgA1 (Gd-IgA1) was assessed at baseline, weeks 4, 12, 24, 48, and 72. Results showed that atacicept, administered subcutaneously once weekly, demonstrated a substantial reduction in serum Gd-IgA1 in a dose-dependent manner that was durable through 72 weeks. New analysis of these results initially divided JANUS patients into four equal groups according to the quartiles of serum Gd-IgA1 distribution at baseline. Quartile level was then assessed at each timepoint. This additional analysis showed that atacicept decreased serum Gd-IgA1 levels by up to two quartiles. The largest effect w...