On Saturday, Vera Therapeutics Inc VERA announced that the Phase 2b ORIGIN 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 at the 60th European Renal Association Congress.
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).
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.
This difference in eGFR was statistically significant (delta 11%, p=0.038) and clinically significant. In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1.
Safety results indicated that atacicept was generally well-tolerated.
Longer-term results, including the ongoing eGFR data from the Phase 2b ORIGIN clinical trial, are planned for presentation later in 2023 and 2024.
Vera continues advancing the pivotal Phase 3 development of atacicept 150 mg. The ORIGIN 3 clinical trial was initiated in June 2023.
Price Action: VERA shares are up 16.80% at $15.03 on the last check Tuesday.
© 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.