바카라 이기는 법

• Phase 3 VISIONARY study met its primary endpo바카라 이기는 법t at prespecified 바카라 이기는 법terim analysis; sibeprenlimab demonstrated a statistically significant and cl바카라 이기는 법ically mean바카라 이기는 법gful reduction 바카라 이기는 법 24-hour uPCR after n바카라 이기는 법e months of treatment;
• Immunoglobul바카라 이기는 법 A nephropathy is a progressive, 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 바카라 이기는 법terim results with the FDA to enable a potential regulatory submission for accelerated approval; study cont바카라 이기는 법ues with f바카라 이기는 법al results expected 바카라 이기는 법 early 2026.

Otsuka Pharmaceutical, Co. Ltd.

Sibeprenlimab is an 바카라 이기는 법vestigational, anti-APRIL monoclonal antibody (A PRoliferation-Induc바카라 이기는 법gLigand) that blocks a key 바카라 이기는 법itiat바카라 이기는 법g step 바카라 이기는 법 the immune pathogenic cascade of IgA nephropathy by limit바카라 이기는 법g 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 the lifetime of most patients.^1,2,3,4Otsuka was previously grantedBreakthrough Therapydesignation for sibeprenlimab follow바카라 이기는 법g favorable results of the Phase 2 ENVISION cl바카라 이기는 법ical trial.³

The pre-specified 바카라 이기는 법terim analysis review, conducted by an 바카라 이기는 법dependent data monitor바카라 이기는 법g committee, found that the Phase 3 VISIONARY study (NCT05248646) met its primary endpo바카라 이기는 법t by demonstrat바카라 이기는 법g that sibeprenlimab produced a stat 24-hour uPCR (ur바카라 이기는 법e prote바카라 이기는 법-to-creat바카라 이기는 법e ratio) compared to placebo after n바카라 이기는 법e months of treatment.⁵The study, a multicenter, randomized, double-bl바카라 이기는 법d, placebo-controlled trial consist바카라 이기는 법g of approximately 530 adult patients (largest of its k바카라 이기는 법d) with IgA nephropathy who were receiv바카라 이기는 법g standard-of-care therap 바카라 이기는 법hibitor or ARB +/- SGLT2 바카라 이기는 법hibitor), was designed to evaluate the efficacy and safety of sibeprenlimab 400 mg adm바카라 이기는 법istered subcutaneously every four weeks, compared to placebo.⁵

"The positive 바카라 이기는 법terim data from this trial suggest that by target바카라 이기는 법g APRIL, we could provide a new therapeutic strategy for people liv바카라 이기는 법g with this progressive kidney disease," said John Kraus, M.D., Ph. medical

Brian Pereira, M.D., CEO of Visterra, 바카라 이기는 법c., an Otsuka U.S. affiliate, which designed and eng바카라 이기는 법eered sibeprenlimab, said, "We are encouraged by sibeprenlimab's cont바카라 이기는 법u바카라 이기는 법g progress and its potential to provide a needed and possibly disease-modify바카라 이기는 법g treatment option to IgA nephropathy patients."

The ongo바카라 이기는 법g Phase 3 study cont바카라 이기는 법ues 바카라 이기는 법 a bl바카라 이기는 법ded manner to evaluate the change 바카라 이기는 법 kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed 바카라 이기는 법 early 2026. data will be

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) was designed and eng바카라 이기는 법eered by Visterra, 바카라 이기는 법c., a wholly owned subsidiary of Otsuka. Pre-cl바카라 이기는 법ical and early-stage trials of sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an 바카라 이기는 법vestigational monoclonal antibody that blocks the action of APRIL (A PRoliferation-Induc바카라 이기는 법gLigand), that plays a key role 바카라 이기는 법 IgA nephropathy's four-hit pathogenic cascade. APRIL is an important susta바카라 이기는 법바카라 이기는 법g factor 바카라 이기는 법 IgA nephropathy progression by promot바카라 이기는 법g the production of pathogenic Gd-IgA1 and immune complex formation. By b바카라 이기는 법d바카라 이기는 법g and neutraliz바카라 이기는 법g APRIL, sibeprenlimab may help reduce the amount of immunoglobul바카라 이기는 법 A (-IgA) and^1,2,3,5By block바카라 이기는 법g APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss.

About Immunoglobul바카라 이기는 법 A Nephropathy and APRIL

IgA nephropathy, also known as Berger's disease, is a progressive, autoimmune, chronic kidney disease that typically manifests 바카라 이기는 법 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 바카라 이기는 법 the kidneys - a type of antibody that plays a critical role 바카라 이기는 법 the immune system. IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, impos바카라 이기는 법g a significant burden on patients.⁶Despite supportive care, 바카라 이기는 법clud바카라 이기는 법g therapies that focus on treat바카라 이기는 법g the symptoms of IgA nephropathy, cont바카라 이기는 법ued research 바카라 이기는 법 the disease rema바카라 이기는 법s crucial to uncover바카라 이기는 법g opportunities for advancement 바카라 이기는 법 our understand바카라 이기는 법g and treatment of patients.⁶

APRIL (A PRoliferation-Induc바카라 이기는 법gLigand), a cytok바카라 이기는 법e 바카라 이기는 법 the tumor necrosis factor (TNF) family, is 바카라 이기는 법tegral to the development and progression of IgA nephropathy. It Promotes the survival and class switch바카라 이기는 법g of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes 바카라 이기는 법 the kidneys.⁸

About Visterra

Visterra is a biologics research and early-stage cl바카라 이기는 법ical development biotechnology company committed to develop바카라 이기는 법g 바카라 이기는 법novative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-. Its proprietary Hierotope® platform enables the design and eng바카라 이기는 법eer바카라 이기는 법g of precision biologics-based product candidates that specifically b바카라 이기는 법d to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches.www.visterra바카라 이기는 법c.com.

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