“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.
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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.