VERA - Vera Therapeutics Presents 72-week eGFR Stabilization and Rapid Hematuria Improvement in Phase 2b ORIGIN Study of Atacicept in IgAN at the 61st European Renal Association Congress | Benzinga
- 72-week data consistent with disease modification in IgAN, selected as a best-ranked abstract;
- Rapid and sustained improvements in hematuria over 36 weeks, with resolution in significantly greater percentage of participants than placebo;
BRISBANE, Calif., May 25, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced data presentations from its Phase 2b ORIGIN trial of atacicept in immunoglobulin A nephropathy (IgAN), showing that atacicept stabilized kidney function through 72 weeks and led to rapid improvements in hematuria. These data were presented at the 61st European Renal Association Congress (ERA24) being held in Stockholm.
"For the first time in this field, we presented 72-week data from our Phase 2b ORIGIN trial showing stable kidney function over the duration of treatment. In addition, we presented data showing that atacicept leads to hematuria resolution in significantly more patients compared with placebo. The impact on hematuria was seen as early as 4 weeks after treatment initiation, which could have important implications for patients with acute kidney inflammation. The evolving atacicept data package supports our belief that atacicept may offer comprehensive disease modification to patients with IgAN," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. "We look forward to presenting the full 96-week data from the Phase 2b ORIGIN trial, which are expected in the fourth quarter of this year."
Participants who received atacicept for 72 weeks had stable eGFR, as well as consistent and sustained reductions in Gd-IgA1, hematuria and UPCR. Participants who switched from placebo to atacicept also demonstrated stable eGFR, as well as similar reductions in Gd-IgA1, hematuria, and UPCR as compared with participants randomized to atacicept during the first 36 weeks of the trial. The cumulative safety profile of atacicept was similar to the randomized period, with a 91% retention rate through 72 weeks. The Company believes these data support the potential for atacicept to offer long-term, comprehensive IgAN disease modification and support the ongoing pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN.
Atacicept 72 Week Results Are Consistent With a Disease-Modifying IgAN Profile
The 72-week abstract was selected as a best-ranked abstract by the ERA24 Congress Paper Selection Committee. The Free Communication oral presentation, titled "Phase 2b ORIGIN Study Open Label Extension with Atacicept in Patients with IgA Nephropathy and Persistent Proteinuria: Week 72 Interim Analysis" was delivered by Dr. Richard Lafayette, Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center.
A post-hoc analysis of the 36-week data from the Phase 2b ORIGIN clinical trial showed that atacicept treatment led to hematuria resolution in a large majority of participants as compared with placebo (80% vs 5%, p<0.001). The atacicept group experienced rapid and sustained reductions in hematuria grade, with shifts to lower hematuria grades seen as early as 4 weeks after treatment initiation, while participants in the placebo group had minimal changes in hematuria grade throughout the randomized 36-week period. These results add to the growing body of evidence supporting atacicept as a potential disease-modifying treatment in IgAN.
Atacicept Led to Significant Hematuria Resolution and Rapid Shifts to Lower Hematuria Grade
The hematuria data was presented in a focused oral titled "Impact of Atacicept on Hematuria ...