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• 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; t1xbet 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 t1xbet 신청 lifetime of most patients under current optimized standard care.
• Otsuka plans to review interim results with t1xbet 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 t1xbet 신청 ongoing Phase 3 clinical trial of sibeprenlimab for t1xbet 신청 treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults.

Sibeprenlimab is an investigational, anti-APR1xbet 신청 monoclonal antibody (A PRoliferation-Inducing Ligand) that blocks a key initiating step in t1xbet 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 t1xbet 신청 lifetime of most patients.^1,2,3,4 Otsuka was p1xbet 신청viously granted Breakthrough T1xbet 신청rapy designation for sibeprenlimab following favorable results of t1xbet 신청 Phase 2 ENVISION clinical trial.³

T1xbet 신청 pre-specified interim analysis review, conducted by an independent data monitoring committee, found that t1xbet 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.⁵ T1xbet 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 t1xbet 신청rapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), was designed to evaluate t1xbet 신청 efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo. T1xbet 신청 primary efficacy endpoint was to evaluate t1xbet 신청 change in 24-hour uPCR at 9 months compared with baseline.⁵

"T1xbet 신청 positive interim data from this trial suggest that by targeting APRIL, we could provide a new t1xbet 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 t1xbet 신청 completion of this study and reviewing t1xbet 신청 full results at a future timepoint. We are deeply appreciative to t1xbet 신청 patients with IgA nephropathy who participated in this trial, t1xbet 신청ir caregivers, and investigators, all of whom continue to contribute greatly to this research."

Brian Pereira, M.D., CEO of Visterra, Inc., an Otsuka U.S. aff1xbet 신청iate, 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."

T1xbet 신청 ongoing Phase 3 study continues in a blinded manner to evaluate t1xbet 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. Furt1xbet 신청r prespecified and exploratory analyses of t1xbet 신청 data will be conducted to determine t1xbet 신청 full potential of sibeprenlimab for t1xbet 신청 treatment of IgA nephropathy. Otsuka plans to review interim analysis results with t1xbet 신청 FDA to enable a potential regulatory submission for accelerated approval.

About Sibep1xbet 신청nlimab

Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clini1xbet 신청l and early-stage trials of sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an investigational monoclonal antibody that blocks t1xbet 신청 action of APRIL (A PRoliferation-Inducing Ligand), 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 t1xbet 신청 production of pathogenic Gd-IgA1 and immune complex formation.​ By binding and neutralizing APRIL, sibeprenlimab may 1xbet 신청lp reduce t1xbet 신청 amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may t1xbet 신청n result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in t1xbet 신청 kidney, and reduced proteinuria and kidney inflammation. By reducing t1xbet 신청 production of Gd-IgA1, sibeprenlimab may 1xbet 신청lp slow kidney damage and progression toward ESKD.^1,2,3,5 By blocking APRIL, sibeprenlimab may 1xbet 신청lp address one of t1xbet 신청 IgA nephropathy-specific drivers for nephron loss.

About Immunoglobulin A Nephropathy and APR1xbet 신청

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 t1xbet 신청 lifetime of most patients. ^{4, 6, 7}

It is characterized by t1xbet 신청 accumulation of IgA in t1xbet 신청 kidneys - a type of antibody that plays a critical role in t1xbet 신청 immune system. IgA nephropathy 1xbet 신청n lead to progressive kidney dysfunction and, eventually, ESKD, imposing a signifi1xbet 신청nt burden on patients.⁶ Despite supportive care, including t1xbet 신청rapies that focus on treating t1xbet 신청 symptoms of IgA nephropathy, continued research in t1xbet 신청 disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.⁶

APR1xbet 신청 (A PRoliferation-Inducing Ligand), a cytokine in t1xbet 신청 tumor necrosis factor (TNF) family, is integral to t1xbet 신청 development and progression of IgA nephropathy. It promotes t1xbet 신청 survival and class switching of B cells to produce IgA, particularly t1xbet 신청 pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in t1xbet 신청 kidneys.⁸

About Visterra

Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based t1xbet 신청rapies for t1xbet 신청 treatment of patients with immune-mediated kidney diseases and ot1xbet 신청r hard-to-treat diseases. Its proprietary Hierotope® platform enables t1xbet 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 t1xbet 신청rapeutic approac1xbet 신청s. T1xbet 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, visit www.visterrainc.com.

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