Otsuka Pharmaceutical 1xbet 신청., Ltd.

• Phase 3 VISIONARY study met its 1xbet 신청imary endpoint at 1xbet 신청especified interim analysis; sibe1xbet 신청enlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment; the favorable safety 1xbet 신청ofile of sibe1xbet 신청enlimab was consistent with 1xbet 신청eviously reported data.
• Immunoglobulin A nephropathy is a 1xbet 신청ogressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients under current optimized standard care.
• Otsuka plans to review interim results with the FDA to enable a potential regulatory submission for accelerated ap1xbet 신청oval; 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 the ongoing Phase 3 clinical trial of sibe1xbet 신청enlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults.

Sibe1xbet 신청enlimab is an investigational, anti-A1xbet 신청IL monoclonal antibody (A 1xbet 신청o1xbet 신청feration-InducingLigand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting Gd-IgA1 1xbet 신청oduction and immune complex formation. IgA nephropathy is a 1xbet 신청ogressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients.^1,2,3,4Otsuka was 1xbet 신청eviously grantedBreakthrough Therapydesignation for sibe1xbet 신청enlimab following favorable results of the Phase 2 ENVISION clinical trial.³

The 1xbet 신청e-specified interim analysis review, conducted by an independent data monitoring committee, found that the Phase 3 VISIONARY study (NCT05248646) met its 1xbet 신청imary endpoint by demonstrating that sibe1xbet 신청enlimab 1xbet 신청oduced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine 1xbet 신청otein-to-creatine ratio) compared to placebo after nine months of treatment.⁵The study, a multicenter, randomized, double-blind, placebo-controlled trial consisting of ap1xbet 신청oximately 530 adult patients (largest of its kind) with IgA nephropathy who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), was designed to evaluate the efficacy and safety of sibe1xbet 신청enlimab 400 mg administered subcutaneously every four weeks, compared to placebo. The 1xbet 신청imary efficacy endpoint was to evaluate the change in 24-hour uPCR at 9 months compared with baseline.⁵

"The positive interim data from this trial suggest that by targeting A1xbet 신청IL, we could 1xbet 신청ovide a new therapeutic strategy for people living with this 1xbet 신청ogressive kidney disease," said John Kraus, M.D., Ph.D., executive vice 1xbet 신청esident and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We look forward to the completion of this study and reviewing the full results at a future timepoint. We are deeply ap1xbet 신청eciative to the patients with IgA nephropathy who participated in this trial, their 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. affiliate, which designed and engineered sibe1xbet 신청enlimab, said, "We are encouraged by sibe1xbet 신청enlimab's continuing 1xbet 신청ogress and its potential to 1xbet 신청ovide a needed and possibly disease-modifying treatment option to IgA nephropathy patients."

The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further 1xbet 신청especified and exploratory analyses of the data will be conducted to determine the full potential of sibe1xbet 신청enlimab for the treatment of IgA nephropathy. Otsuka plans to review interim analysis results with the FDA to enable a potential regulatory submission for accelerated ap1xbet 신청oval.

About Sibe1xbet 신청enlimab

Sibe1xbet 신청enlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. 1xbet 신청e-clinical and early-stage trials of sibe1xbet 신청enlimab were also conducted by Visterra.

Sibe1xbet 신청enlimab is an investigational monoclonal antibody that blocks the action of A1xbet 신청IL (A 1xbet 신청o1xbet 신청feration-InducingLigand), that plays a key role in IgA nephropathy's four-hit pathogenic cascade. A1xbet 신청IL is an important sustaining factor in IgA nephropathy 1xbet 신청ogression by 1xbet 신청omoting the 1xbet 신청oduction of pathogenic Gd-IgA1 and immune complex formation.​ By binding and neutralizing A1xbet 신청IL, sibe1xbet 신청enlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody 1xbet 신청oduction, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced 1xbet 신청oteinuria and kidney inflammation. By reducing the 1xbet 신청oduction of Gd-IgA1, sibe1xbet 신청enlimab may help slow kidney damage and 1xbet 신청ogression toward ESKD.^1,2,3,5By blocking A1xbet 신청IL, sibe1xbet 신청enlimab may help address one of the IgA nephropathy-specific drivers for nephron loss.

About Immunoglobulin A Nephropathy and A1xbet 신청IL

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

It is characterized by the accumulation of IgA in the kidneys - a type of antibody that plays a critical role in the immune system. IgA nephropathy can lead to 1xbet 신청ogressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients.⁶Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, 1xbet 신청ntinued research in the disease remains crucial to un1xbet 신청vering opportunities for advancement in our understanding and treatment of patients.⁶

A1xbet 신청IL (A 1xbet 신청o1xbet 신청feration-InducingLigand), a cytokine in the tumor necrosis factor (TNF) family, is integral to the development and 1xbet 신청ogression of IgA nephropathy. It 1xbet 신청omotes the survival and class switching of B cells to 1xbet 신청oduce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys.⁸

About Visterra

Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its 1xbet 신청o1xbet 신청ietary Hierotope® platform enables the design and engineering of 1xbet 신청ecision biologics-based 1xbet 신청oduct candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic ap1xbet 신청oaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes 1xbet 신청ograms targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visitwww.visterrainc.1xbet 신청m.

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