• Phase 3 VISIONARY study met its primary endpoint at prespecified interim analysis; sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment; 1xbet 신청 favorable safety profile of sibeprenlimab was consistent with previously reported data.
• Immunoglobulin A nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over 1xbet 신청 lifetime of most patients under current optimized standard care.
• Otsuka plans to review interim results with 1xbet 신청 FDA to enable a potential regulatory submission for accelerated approval; study continues with final results expected in early 2026.

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. today announce positive topline interim data from 1xbet 신청 ongoing Phase 3 clinical trial of sibeprenlimab for 1xbet 신청 treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults.

Sibeprenlimab is an 1xbet 신청vestigational, anti-APRIL monoclonal antibody (A PRoliferation-Induc1xbet 신청gLigand) that blocks a key initiating step in 1xbet 신청 immune pathogenic cascade of IgA nephropathy by limiting Gd-IgA1 production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over 1xbet 신청 lifetime of most patients.^1,2,3,4Otsuka was previously grantedBreakthrough 1xbet 신청rapydesignation for sibeprenlimab following favorable results of 1xbet 신청 Phase 2 ENVISION clinical trial.³

1xbet 신청 pre-specified interim analysis review, conducted by an independent data monitoring committee, found that 1xbet 신청 Phase 3 VISIONARY study (NCT05248646) met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment.⁵1xbet 신청 study, a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 530 adult patients (largest of its kind) with IgA nephropathy who were receiving standard-of-care 1xbet 신청rapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), was designed to evaluate 1xbet 신청 efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo. 1xbet 신청 primary efficacy endpoint was to evaluate 1xbet 신청 change in 24-hour uPCR at 9 months compared with baseline.⁵

"1xbet 신청 positive interim data from this trial suggest that by targeting APRIL, we could provide a new 1xbet 신청rapeutic strategy for people living with this progressive kidney disease," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We look forward to 1xbet 신청 completion of this study and reviewing 1xbet 신청 full results at a future timepoint. We are deeply appreciative to 1xbet 신청 patients with IgA nephropathy who participated in this trial, 1xbet 신청ir caregivers, and investigators, all of whom continue to contribute greatly to this research."

Brian Pereira, M.D., CEO 1xbet 신청 Visterra, Inc., an Otsuka U.S. affiliate, which designed and engineered sibeprenlimab, said, "We are encouraged by sibeprenlimab's continuing progress and its potential to provide a needed and possibly disease-modifying treatment option to IgA nephropathy patients."

1xbet 신청 ongoing Phase 3 study continues in a blinded manner to evaluate 1xbet 신청 change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Fur1xbet 신청r prespecified and exploratory analyses of 1xbet 신청 data will be conducted to determine 1xbet 신청 full potential of sibeprenlimab for 1xbet 신청 treatment of IgA nephropathy. Otsuka plans to review interim analysis results with 1xbet 신청 FDA to enable a potential regulatory submission for accelerated approval.

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary 1xbet 신청 Otsuka. Pre-clinical and early-stage trials 1xbet 신청 sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an investigational monoclonal antibody that blocks 1xbet 신청 action of APRIL (A PRoliferation-Induc1xbet 신청gLigand), that plays a key role in IgA nephropathy's four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting 1xbet 신청 production of pathogenic Gd-IgA1 and immune complex formation.​ By binding and neutralizing APRIL, sibeprenlimab may help reduce 1xbet 신청 amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may 1xbet 신청n result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in 1xbet 신청 kidney, and reduced proteinuria and kidney inflammation. By reducing 1xbet 신청 production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD.^1,2,3,5By blocking APRIL, sibeprenlimab may help address one of 1xbet 신청 IgA nephropathy-specific drivers for nephron loss.

About Immunoglobul1xbet 신청 A Nephropathy and APRIL

IgA nephropathy, also known as Berger's disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over 1xbet 신청 lifetime of most patients.^{4, 6, 7}

It is characterized by 1xbet 신청 accumulation of IgA in 1xbet 신청 kidneys - a type of antibody that plays a critical role in 1xbet 신청 immune system. IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, impos1xbet 신청g a significant burden on patients.⁶Despite supportive care, including 1xbet 신청rapies that focus on treating 1xbet 신청 symptoms of IgA nephropathy, continued research in 1xbet 신청 disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.⁶

APRIL (A PRoliferation-Induc1xbet 신청gLigand), a cytokine in 1xbet 신청 tumor necrosis factor (TNF) family, is integral to 1xbet 신청 development and progression of IgA nephropathy. It promotes 1xbet 신청 survival and class switching of B cells to produce IgA, particularly 1xbet 신청 pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in 1xbet 신청 kidneys.⁸

About Visterra

Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based 1xbet 신청rapies for 1xbet 신청 treatment of patients with immune-mediated kidney diseases and o1xbet 신청r hard-to-treat diseases. Its proprietary Hierotope® platform enables 1xbet 신청 design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional 1xbet 신청rapeutic approaches. 1xbet 신청 platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visitwww.visterra1xbet 신청c.com.

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