Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. have announced positive topline interim results from their ongoing Phase 3 clinical trial of sibeprenlimab for treating immunoglobulin A nephropathy (IgA nephropathy) in adults.
Sibeprenlimab is an investigational anti-APRIL monoclonal antibody that inhibits a critical step in the immune response associated with IgA nephropathy, a progressive autoimmune kidney disease that can lead to end-stage kidney disease (ESKD). Otsuka previously received Breakthrough Therapy designation for sibeprenlimab based on favorable Phase 2 results.
The interim analysis, conducted by an independent data monitoring committee, revealed that the Phase 3 VISIONARY study (NCT05248646) met its primary endpoint. The trial showed a statistically significant reduction in 24-hour urine protein-to-creatinine ratio (uPCR) for sibeprenlimab compared to placebo after nine months. This multicenter, randomized, double-blind study involved approximately 530 adult patients receiving standard-of-care therapy, evaluating the efficacy and safety of sibeprenlimab administered subcutaneously every four weeks.
Dr. John Kraus, Otsuka’s Chief Medical Officer, stated, “These positive interim results suggest that targeting APRIL could offer a new treatment approach for individuals with this chronic kidney condition.” He expressed gratitude to the trial participants and researchers involved.
Brian Pereira, CEO of Visterra, Inc., the subsidiary that developed sibeprenlimab, noted the drug’s potential as a much-needed treatment option for IgA nephropathy patients.
The ongoing Phase 3 study will continue to assess kidney function over 24 months and is expected to conclude in early 2026. Otsuka plans to discuss these interim results with the FDA to potentially expedite regulatory approval.
About Sibeprenlimab
Sibeprenlimab, developed by Visterra, is designed to block APRIL, a cytokine that plays a significant role in the progression of IgA nephropathy. By neutralizing APRIL, sibeprenlimab may reduce the production of pathogenic Gd-IgA1 and immune complexes, potentially slowing kidney damage.
About IgA Nephropathy
IgA nephropathy, or Berger’s disease, is a chronic kidney condition that often manifests in young adults and can lead to ESKD. It involves the buildup of IgA antibodies in the kidneys, resulting in kidney dysfunction.
About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company focused on innovative pharmaceutical and nutraceutical products. With a presence in the U.S. since 1973, Otsuka is committed to addressing unmet medical needs in mental health, nephrology, and other areas.
About Visterra
Visterra is a biotechnology company dedicated to developing antibody-based therapies for immune-mediated kidney diseases and other challenging conditions, leveraging its proprietary technology platform to create targeted treatment options.
