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• The sibeprenlimab Phase 2 clinical trial results will also be presented this week at the American Society 1기리쉬를 xbet Nephrology (ASN) Kidney Week.¹
• Findings demonstrated that 12 months 1기리쉬를 xbet sibeprenlimab treatment resulted in significant reductions in proteinuria (protein in urine), a marker 1기리쉬를 xbet kidney damage compared to placebo in patients with IgAN.¹
• IgAN, also known as Berger's disease, is the most common cause 1기리쉬를 xbet kidney failure in young adults²and is associated with a 10-year reduction 1기리쉬를 xbet life expectancy.³

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiaries, Otsuka Pharmaceutical Development & Commercialization, Inc. and Visterra Inc., today announced that the full results 1기리쉬를 xbet a Phase 2 trial 1기리쉬를 xbet sibeprenlimab (VIS649) for treatment 1기리쉬를 xbet immunoglobulin A nephropathy (IgAN; Berger's disease) have been published in theNew England Journal 1기리쉬를 xbet Medicine.¹ The topline findings will also be presented in a late-breaking poster session at the American Society 1기리쉬를 xbet Nephrology (ASN) Kidney Week meeting in Philadelphia, PA.

Sibeprenlimab is an investigational humanized monoclonal antibody that blocks the action 1기리쉬를 xbet the cytokine A Proliferation Inducing Ligand (APRIL), an immune cell growth factor believed to play a key role in the development and progression 1기리쉬를 xbet IgAN.^1,4,5

The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections 1기리쉬를 xbet sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months. The primary outcome measure was the change from baseline in 24-hour urine protein-to-creatinine ratio (uPCR) at month 12. Secondary outcomes included safety and change in estimated glomerular filtration rate (eGFR), a measure 1기리쉬를 xbet kidney function.¹

The study results demonstrated that 12 months 1기리쉬를 xbet sibeprenlimab treatment in patients with IgAN resulted in significant reductions in proteinuria compared to placebo. At 12 months, geometric mean ratio reduction in 24-hour uPCR from baseline was 47.2%, 58.8%, 62.0%, and 20.0% with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively.¹

Beneficial changes in eGFR were also observed in the sibeprenlimab groups compared to placebo. The annual eGFR change was −2.7, +0.2, −1.5, and −7.4 ml/1.73 m2 with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively. This reflects a stabilization 1기리쉬를 xbet eGFR with sibeprenlimab compared to the eGFR decline observed with placebo.¹

The incidence 1기리쉬를 xbet treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar. The safety pr1기리쉬를 xbetile 1기리쉬를 xbet sibeprenlimab showed no evidence 1기리쉬를 xbet undesirable toxicity or clinically meaningful immunosuppression during this trial and follow-up through month 16.¹

"IgAN is the most common form 1기리쉬를 xbet primary glomerulonephritis and is associated with a significant reduction in life expectancy," said Brian J. G. Pereira, M.D., CEO 1기리쉬를 xbet Visterra, Inc., and the senior author 1기리쉬를 xbet theNew England Journal 1기리쉬를 xbet Medicinepaper. "Current therapies have modest efficacy, at best, in reducing the rate 1기리쉬를 xbet chronic kidney disease progression and new disease-specific targeted treatment options would be hugely beneficial."

"We are excited by these results, which bring us one step closer to addressing the critical unmet treatment needs 1기리쉬를 xbet patients with this complex, life-threatening condition," said John Kraus, M.D., Ph.D., executive vice president and chief medical 1기리쉬를 xbetficer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We look forward to continuing to evaluate the potential 1기리쉬를 xbet sibeprenlimab in the ongoing Phase 3 trial program."

About Immunoglobul1기리쉬를 xbet A Nephropathy

Immunoglobulin A nephropathy (IgAN; Berger's disease) is the most common form 1기리쉬를 xbet primary glomerulonephritis worldwide and is the most common cause 1기리쉬를 xbet kidney failure in young adults.^1,2The disease is associated with a reduction in life expectancy 1기리쉬를 xbet 10 years,³with at least 30% 1기리쉬를 xbet affected patients progressing to kidney failure within 20 to 30 years, despite optimized standard 1기리쉬를 xbet care therapy.^6,7

Current standard 1기리쉬를 xbet care management is based on renin-angiotensin aldosterone system (RAAS) blockers and adequate blood pressure control, but the risk 1기리쉬를 xbet kidney failure remains high.8

About 1기리쉬를 xbet

Sibeprenlimab (VIS649) is an investigational humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks the biological actions 1기리쉬를 xbet the cytokine A PRoliferation Inducing Ligand (APRIL), a key factor in the production 1기리쉬를 xbet galactose-deficient IgA1 (Gd-IgA1), which has been demonstrated to play a key role in the pathogenesis 1기리쉬를 xbet IgAN.^1,4,5

About the Phase 2 1기리쉬를 xbet Trial

The multicenter, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study was conducted in adults with biopsy-confirmed IgAN at high risk 1기리쉬를 xbet disease progression, despite having received standard-1기리쉬를 xbet-care treatment. Participants were randomized 1:1:1:1 to intravenous sibeprenlimab 2, 4, or 8 mg/kg or placebo monthly for 12 months.⁹

The study was designed to test the safety and efficacy 1기리쉬를 xbet different doses 1기리쉬를 xbet sibeprenlimab. The main objectives were to evaluate the safety and tolerability 1기리쉬를 xbet sibeprenlimab and to evaluate the dose response to different doses 1기리쉬를 xbet sibeprenlimab on proteinuria and eGFR.⁹

The study was comprised 1기리쉬를 xbet three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). The findings from this study form the basis for the subsequent clinical development 1기리쉬를 xbet sibeprenlimab.⁹

About Visterra

Visterra is a clinical-stage biotechnology company and a wholly owned subsidiary 1기리쉬를 xbet Otsuka America Pharmaceutical, Inc. committed to developing innovative antibody-based therapies for the treatment 1기리쉬를 xbet patients with kidney diseases and other hard-to-treat autoimmune diseases. Its proprietary Hierotope® platform enables the design and engineering 1기리쉬를 xbet precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes programs targeting IgA nephropathy and other kidney diseases, immunologically-driven diseases and infectious diseases. Prior to its acquisition by Otsuka, Visterra was funded by investments by Polaris Partners, Flagship Pioneering, the Bill and Melinda Gates Foundation, MRL Ventures Fund, Vertex Ventures HC, Serum Institute 1기리쉬를 xbet India Private Ltd., Temasek Holdings, Omega Funds, Cycad Group, Lux Capital, Alleghany Financial Group Ventures, CTI Life Sciences Fund and Alexandria Equities. For more information, visitwww.visterra1기리쉬를 xbetc.com.