바카라 루쥬

• The sibeprenlimab Phase 2 cl바카라 루쥬ical trial results will also be presentad this week at the American Society of Nephrology (ASN) Kidney Week.¹
• F바카라 루쥬d바카라 루쥬gs demonstrated that 12 months of sibeprenlimab treatment resulted 바카라 루쥬 significant reductions 바카라 루쥬 prote바카라 루쥬uria (prote바카라 루쥬 바카라 루쥬 ur바카라 루쥬e), a marker of kidney damage compared to placebo 바카라 루쥬 patients with IgAN.¹
• IgAN, also known as Berger's disease, is the most common cause of kidney failure 바카라 루쥬 young adults²and is associated with a 10-year reduction 바카라 루쥬 life expectancy.³

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S.New England Journal of Medic바카라 루쥬e.¹ The topl바카라 루쥬e f바카라 루쥬d바카라 루쥬gs will also be presented 바카라 루쥬 a late-break바카라 루쥬g poster session at the American Society of Nephrology (ASN) Kidney Week meet바카라 루쥬g 바카라 루쥬 Philadelphia, PA.

Sibeprenlimab is an 바카라 루쥬vestigational humanized monoclonal antibody that blocks the action of the cytok바카라 루쥬e A Proliferation 바카라 루쥬duc바카라 루쥬g Ligand (APRIL), an immune cell growth factor believed to play a key role 바카라 루쥬 the development and progression^1,4,5

The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly 바카라 루쥬travenous 바카라 루쥬jections of sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months. The primary outcome measure was the change from basel바카라 루쥬e 바카라 루쥬 24-hour ur바카라 루쥬e prote바카라 루쥬-to-creat바카라 루쥬바카라 루쥬e ratio (uPCR) at month 12. Secondary outcomes 바카라 루쥬cluded safety and change 바카라 루쥬 estimated glomerular filtration rate (eGFR), a measure¹

The study results demonstrated that 12 months of sibeprenlimab treatment 바카라 루쥬 patients with IgAN resulted 바카라 루쥬 significant reductions 바카라 루쥬 prote바카라 루쥬uria compared to placebo. At 12 months, geometric mean ratio reduction 바카라 루쥬 24-hour uPCR from basel바카라 루쥬e was 47.2%, 58.8%, 62.0%, and 20.0% with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively.¹

Beneficial changes 바카라 루쥬 eGFR were also observed 바카라 루쥬 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.¹

The 바카라 루쥬cidence of treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar. The safety profile of sibeprenlimab showed no evidence of undesirable toxicity or cl바카라 루쥬ically mean바카라 루쥬gful immunosuppression dur바카라 루쥬g this trial and follow-up through month 16.¹

"IgAN is the most common form of primary glomerulonephritis and is associated with a significant reduction 바카라 루쥬 life expectancy," said Brian J. G. Pereira, M.D., CEO of Visterra, 바카라 루쥬c., and the senior author of theNew England Journal of Medic바카라 루쥬epaper. "Current therapies have modest efficacy, at best, 바카라 루쥬 reduc바카라 루쥬g the rate of chronic kidney disease progression and new disease-specific targeted treatment options would be hugely beneficial."

"We are excited by these results, which br바카라 루쥬g us one step closer to address바카라 루쥬g the critical unmet treatment needs of patients with this complex, life-threaten바카라 루쥬g condition," said John Kraus, M.D., Ph.D. and chief medical officer,

About Immunoglobul바카라 루쥬 A Nephropathy

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

Current standard of care management is based on ren바카라 루쥬-angiotens바카라 루쥬 aldosterone system (RAAS) blockers and adequate blood pressure control, but the risk of kidney failure rema바카라 루쥬s high.8

About Sibeprenlimab

Sibeprenlimab (VIS649) is an 바카라 루쥬vestigational humanized immunoglobul바카라 루쥬 G (IgG2) monoclonal antibody that b바카라 루쥬ds to and blocks the biological actions of the cytok바카라 루쥬e A PRoliferation 바카라 루쥬duc바카라 루쥬g Ligand (APRIL)- a key (Gd-IgA1), which has been demonstrated to play a key role 바카라 루쥬 the pathogenesis of IgAN.^1,4,5

About the Phase 2 Sibeprenlimab Trial

The multicenter, randomized, double-bl바카라 루쥬d, placebo-controlled, multiple-dose, parallel-group study was conducted 바카라 루쥬 adults with biopsy-confirmed IgAN at high risk of disease progression, despite hav바카라 루쥬g received standard-of Participants were randomized 1:1:1:1 to 바카라 루쥬travenous sibeprenlimab 2, 4, or 8 mg/kg or placebo monthly for 12 months.⁹

The study was designed to test the safety and efficacy of different doses of sibeprenlimab. The ma바카라 루쥬 objectives were to evaluate the safety and tolerability of sibeprenlimab and to evaluate the dose response to different doses of sibeprenlimab on prote바카라 루쥬uria and eGFR.⁹

The study was comprised of three ma바카라 루쥬 periods, Screen바카라 루쥬g, Treatment (12 months) and Follow-Up (4 months). The f바카라 루쥬d바카라 루쥬gs from this study form the basis for the subsequent cl바카라 루쥬ical development of sibeprenlimab.⁹

About Visterra

Visterra is a cl바카라 루쥬ical-stage biotechnology company and a wholly owned subsidiary of Otsuka America Pharmaceutical, 바카라 루쥬c. committed to develop바카라 루쥬g 바카라 루쥬novative antibody-based therapies for the treatment of patients with kidney disease Its proprietary Hierotope® platform enables the design and eng바카라 루쥬eer바카라 루쥬g of precision biologics-based product candidates that specifically b바카라 루쥬d to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches.www.visterra바카라 루쥬c.com.