ベラ・セラピューティクス【VERA】の掲示板

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Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually.

Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACEi or ARB therapy.

At week 36 in the prespecified per-protocol (PP) analysis, the atacicept 150 mg dose group showed a 43% placebo-adjusted reduction from baseline in proteinuria (p=0.003), compared to 35% in the intent-to-treat (ITT) analysis (p=0.012), as shown in Figure 1 below.
In the ITT analysis of all randomized patients, patients receiving placebo had an expected decline in kidney function as measured by eGFR, while patients receiving atacicept 150 mg had stable eGFR through week 36, as shown in Figure 2. This difference in eGFR was statistically significant (delta 11%, p=0.038) and clinically significant (5.8 mL/min/1.73 m2). In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1 (p<0.0001).

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“The week 36 results of the Phase 2b ORIGIN clinical trial build on a growing body of data that demonstrates atacicept's potential to modify and delay disease progression in IgAN. We believe this is best characterized by the early signs of eGFR stabilization and a significant 43% reduction in proteinuria for the atacicept 150 mg group compared to placebo,” said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center. “These data also demonstrate the therapeutic potential of the BLyS and APRIL dual inhibitor approach to treating the root cause of IgAN.”
“With these results from the Phase 2b ORIGIN clinical trial at week 36, we believe the clinical results we have generated support atacicept as a potentially disease-modifying therapy for patients with IgAN,” said Marshall Fordyce, M.D., Chief Executive Officer of Vera Therapeutics. “With our confirmatory Phase 3 ORIGIN 3 clinical trial already recruiting, we are working to bring this potentially transformative therapy to patients with IgAN as quickly as possible with guidance from regulators and look forward to sharing future updates on our progress.”
Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, with no increased rate of infections compared to placebo, a low rate (2%) of serious adverse events overall, and no drug discontinuations or interruptions due to hypogammaglobulinemia. Serious treatment-emergent adverse events (TEAEs) were observed in 3% of patients receiving atacicept 150 mg and in 9% of placebo patients. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date across different indications – in which atacicept was well-tolerated.