Kidney Disease-Focused Vera Therapeutics Concludes Enrollment In Pivotal Study, Targets 2026 Commercial Launch

Vera Therapeutics, Inc. VERA said on Wednesday that it had completed full enrollment (431 participants) in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN).

ORIGIN 3 follows the long-term results from the ORIGIN Phase 2b trial, which demonstrated sustained and substantial reductions in Gd-IgA1, hematuria, and proteinuria and showed stabilized kidney function through 96 weeks.

The company anticipates the 36-week primary efficacy endpoint data from the trial this quarter, which supports planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025.

Also Read: Vera Therapeutics' Atacicept Shows Sustained, Substantial Improvement In Kidney Function For Patients At Almost Two Years

Pending the submission and FDA review of the BLA, the company said it looks forward to a potential PDUFA date and commercial launch in 2026.

The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria and remain at high risk of disease progression.

Participants are randomized 1:1 to at-home self-administered once-weekly subcutaneous injections of atacicept 150 mg or placebo for a 104-week double-blind period, followed by a 52-week open-label extension.

The primary efficacy endpoint is the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) through 36 weeks in an interim analysis of at least 200 participants.

The key secondary efficacy endpoint is a change in kidney function measured by estimated glomerular filtration rate (eGFR) through 104 weeks in the full study population.

In addition, the company is currently conducting the ORIGIN Extend trial, which provides extended access to atacicept for participants from the ORIGIN Phase 2b or Phase 3 trials until commercial availability in their region and captures longer-term safety and efficacy data.

Vera Therapeutics Stock Prediction For 2025

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Price Action: VERA stock is up 14.60% at $21.62 at the last check Wednesday.

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