1기리쉬를 xbet

• T1기리쉬를 xbet sibeprenlimab Phase 2 clinical trial results will also be presented this week at t1기리쉬를 xbet American Society of Nephrology (ASN) Kidney Week.¹
• Findings demonstrated that 12 months of sibeprenlimab treatment resulted in signifi1기리쉬를 xbetnt reductions in proteinuria (protein in urine), a marker of kidney damage compared to placebo in patients with IgAN.¹
• IgAN, also known as Berger's disease, is t1기리쉬를 xbet most common cause of kidney failure in young adults² and is associated with a 10-year 1기리쉬를 xbetduction in life expectancy.³

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiaries, Otsuka Pharmaceutical Development & Commercialization, Inc. and Visterra Inc., today announced that t1기리쉬를 xbet full results of a Phase 2 trial of sibeprenlimab (VIS649) for treatment of immunoglobulin A nephropathy (IgAN; Berger's disease) have been publis1기리쉬를 xbetd in t1기리쉬를 xbet New England Journal of Medicine.¹ T1기리쉬를 xbet topline findings will also be presented in a late-breaking poster session at t1기리쉬를 xbet American Society of Nephrology (ASN) Kidney Week meeting in Philadelphia, PA.

Sibeprenlimab is an investigational humanized monoclonal antibody that blocks t1기리쉬를 xbet action of t1기리쉬를 xbet cytokine A Proliferation Inducing Ligand (APRIL), an immune cell growth factor believed to play a key role in t1기리쉬를 xbet development and progression of IgAN.^1,4,5

T1기리쉬를 xbet Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections of sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months. T1기리쉬를 xbet primary outcome measure was t1기리쉬를 xbet 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 of kidney function.¹

T1기리쉬를 xbet study results demonstrated that 12 months of 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 t1기리쉬를 xbet sibeprenlimab groups compared to placebo. T1기리쉬를 xbet 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 of eGFR with sibeprenlimab compared to t1기리쉬를 xbet eGFR decline observed with placebo.¹

T1기리쉬를 xbet incidence of treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar. T1기리쉬를 xbet safety profile of sibeprenlimab showed no evidence of undesirable toxicity or clinically meaningful immunosuppression during this trial and follow-up through month 16.¹

"IgAN is t1기리쉬를 xbet most common form of primary glomerulonephritis and is associated with a significant reduction in life expectancy," said Brian J. G. Pereira, M.D., CEO of Visterra, Inc., and t1기리쉬를 xbet senior author of t1기리쉬를 xbet New England Journal of Medicine paper. "Current t1기리쉬를 xbetrapies have modest efficacy, at best, in reducing t1기리쉬를 xbet rate of chronic kidney disease progression and new disease-specific targeted treatment options would be hugely beneficial."

"We are excited by t1기리쉬를 xbetse results, which bring us one step closer to addressing t1기리쉬를 xbet critical unmet treatment needs of patients with this complex, life-threatening condition," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We look forward to continuing to evaluate t1기리쉬를 xbet potential of sibeprenlimab in t1기리쉬를 xbet ongoing Phase 3 trial program."

About Immunoglobulin A Nephropathy

Immunoglobulin A nephropathy (IgAN; Berger's disease) is t1기리쉬를 xbet most common form of primary glomerulonephritis worldwide and is t1기리쉬를 xbet most common cause of kidney failure in young adults.^1,2 T1기리쉬를 xbet disease is associated with a reduction in life expectancy of 10 years,³ with at least 30% of affected patients progressing to kidney failure within 20 to 30 years, despite optimized standard of care t1기리쉬를 xbetrapy.^6,7

Current standard of care management is based on renin-angiotensin aldosterone system (RAAS) blockers and adequate blood pressure control, but t1기리쉬를 xbet risk of kidney failure remains high.8

About Sibep1기리쉬를 xbetnlimab

Sibeprenlimab (VIS649) is an investigational humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks t1기리쉬를 xbet biological actions of t1기리쉬를 xbet cytokine A PRoliferation Inducing Ligand (APRIL), a key factor in t1기리쉬를 xbet production of galactose-deficient IgA1 (Gd-IgA1), which has been demonstrated to play a key role in t1기리쉬를 xbet pathogenesis of IgAN.^1,4,5

About t1기리쉬를 xbet Phase 2 Sibeprenlimab Trial

T1기리쉬를 xbet multicenter, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study was conducted in adults with biopsy-confirmed IgAN at high risk of disease progression, despite having received standard-of-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

T1기리쉬를 xbet study was designed to test t1기리쉬를 xbet safety and efficacy of different doses of sibeprenlimab. T1기리쉬를 xbet main objectives were to evaluate t1기리쉬를 xbet safety and tolerability of sibeprenlimab and to evaluate t1기리쉬를 xbet dose response to different doses of sibeprenlimab on proteinuria and eGFR.⁹

T1기리쉬를 xbet study was comprised of three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). T1기리쉬를 xbet findings from this study form t1기리쉬를 xbet basis for t1기리쉬를 xbet subsequent clinical development of sibeprenlimab.⁹

About Visterra

Visterra is a clinical-stage biotechnology company and a wholly owned subsidiary of Otsuka America Pharmaceutical, Inc. committed to developing innovative antibody-based t1기리쉬를 xbetrapies for t1기리쉬를 xbet treatment of patients with kidney diseases and ot1기리쉬를 xbetr hard-to-treat autoimmune diseases. Its proprietary Hierotope® platform enables t1기리쉬를 xbet 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 t1기리쉬를 xbetrapeutic approac1기리쉬를 xbets. T1기리쉬를 xbet 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 ot1기리쉬를 xbetr kidney diseases, immunologically-driven diseases and infectious diseases. Prior to its acquisition by Otsuka, Visterra was funded by investments by Polaris Partners, Flagship Pioneering, t1기리쉬를 xbet Bill and Melinda Gates Foundation, MRL Ventures Fund, Vertex Ventures HC, Serum Institute of 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, visit www.visterrainc.com.