Phase 2b ORIGIN OLE: 72-Week eGFR Stability with Vera Therapeutics in IgA Nephropathy

Vera Therapeutics, a clinical-stage biotechnology firm, has reported promising 72-week results from the open-label extension (OLE) of its Phase 2b ORIGIN clinical trial. The study focused on atacicept, an experimental treatment for IgA nephropathy (IgAN), a progressive autoimmune kidney disease. The data revealed sustained reductions in key disease indicators such as Gd-IgA1, hematuria, and urine protein to creatinine ratio (UPCR), along with stable estimated glomerular filtration rate (eGFR) in patients treated with atacicept for 72 weeks.

The OLE data underscored the potential of atacicept as a disease-modifying therapy for IgAN. Richard Lafayette, M.D., a professor of medicine and nephrology at Stanford University, highlighted the significance of maintaining stable eGFR over an extended period, which could revolutionize treatment approaches for the disease. The OLE results also showed that patients initially on placebo who switched to atacicept experienced halted eGFR decline and similar reductions in Gd-IgA1, hematuria, and UPCR.

Marshall Fordyce, M.D., CEO of Vera Therapeutics, expressed excitement about the positive data and its implications for the ongoing pivotal Phase 3 ORIGIN 3 clinical trial. The Phase 2b ORIGIN trial included 116 patients with IgAN who were treated with atacicept or placebo for 36 weeks, followed by an OLE period where all participants received atacicept. The primary endpoint of the trial was the change in proteinuria as evaluated by UPCR at week 24, with key secondary endpoints at weeks 36 and 96.

Atacicept is an investigational recombinant fusion protein that targets B cells and plasma cells to reduce autoantibody production associated with autoimmune diseases like IgAN. The drug has demonstrated a favorable safety profile in over 1,500 participants across various indications in clinical trials.

IgAN, also known as Berger's disease, is a serious autoimmune condition that can lead to end-stage renal disease in up to 50 percent of patients. Vera Therapeutics is committed to developing treatments that address the root cause of immunologic diseases, aiming to improve the standard of care for patients.

The positive OLE findings have bolstered Vera Therapeutics' confidence in atacicept's potential as a transformative treatment for IgAN. The company is progressing with the pivotal Phase 3 ORIGIN 3 trial, which is designed to further evaluate atacicept's safety and efficacy in a larger patient population. The results of the Phase 2b trial and the ongoing Phase 3 trial are expected to provide valuable insights into the future treatment paradigm for IgAN patients.