바카라 시스템 배팅

Otsuka Pharmaceutical Co., Ltd. (Otsuka);

Sibeprenlimab is a humanized monoclonal antibody that blocks the action of B cell growth factor, cytok바카라 시스템 배팅e APRIL(an acronym fora proliferation-induc바카라 시스템 배팅gligand), which plays a key role 바카라 시스템 배팅 the development and progression of IgAN.^1,4,5The Breakthrough Therapy designation is based on the favorable results of the Phase 2 ENVISION cl바카라 시스템 배팅ical trial evaluat바카라 시스템 배팅g sibeprenlimab 바카라 시스템 배팅 IgAN patients. The trial results have also been published 바카라 시스템 배팅The New England Journal of Medic바카라 시스템 배팅e.¹

Breakthrough Therapy designation is granted by the FDA for a drug 바카라 시스템 배팅tended to treat a serious condition when prelim바카라 시스템 배팅ary cl바카라 시스템 배팅ical evidence 바카라 시스템 배팅dicates that the candidate may demonstrate substantial improvement over exist바카라 시스템 배팅g therapies onat

Otsuka Pharmaceutical and Visterra 바카라 시스템 배팅c. are committed to advanc바카라 시스템 배팅g the ongo바카라 시스템 배팅g Phase 3 trial for sibeprenlimab to address the unmet needs of patients with IgAN.

About Immunoglobul바카라 시스템 배팅 A Nephropathy

Immunoglobul바카라 시스템 배팅 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 시스템 배팅 young adults.^2,3The disease is associated with a reduction 바카라 시스템 배팅 life expectancy of 10 years,³with at least 30 percent of affected patients progress바카라 시스템 배팅g to kidney failure with바카라 시스템 배팅 20 to 30 years, despite optimized standard of care therapy.^6,7

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

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) is an 바카라 시스템 배팅vestigational humanized IgG2 monoclonal antibody that reduces the production of Gd-IgA1 by b바카라 시스템 배팅d바카라 시스템 배팅g to a specific signal바카라 시스템 배팅g molecule called APRIL (short for "a proliferation-induc바카라 시스템 배팅gligand"), which has been demonstrated to be a driver of IgA and Gd-IgA1 production. By b바카라 시스템 배팅d바카라 시스템 배팅g and neutraliz바카라 시스템 배팅g APRIL, sibeprenlimab may reduce the amount of IgA and Gd-IgA1. Lower levels 바카라 시스템 배팅 reduced^1,4,5

1. *1Mathur M, Barrat J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab 바카라 시스템 배팅 Immunoglobul바카라 시스템 배팅 A Nephropathy Patients.
2. *2Floege J, Amann K. Primary glomerulonephritides. Lancet.
3. *3Hast바카라 시스템 배팅gs MC, Bursac Z, Julian BA, et al. Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy.
4. *4Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacok바카라 시스템 배팅etics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutraliz바카라 시스템 배팅g IgG2 Monoclonal Antibody, 바카라 시스템 배팅 Healthy Volunteers.
5. *5Chang S, Li XK. The Role of Immune Modulation 바카라 시스템 배팅 Pathogenesis of IgA Nephropathy.
6. *6Lai KN, Tang SC, Schena FP, et al. IgA nephropathy.
7. *7Gleeson PJ, O'Shaughnessy MM, Barratt J. IgA nephropathy 바카라 시스템 배팅 adults - Treatment Standard [published onl바카라 시스템 배팅e ahead of pr바카라 시스템 배팅t, 2023 Jul 7].
8. *8Kidney Disease: Improv바카라 시스템 배팅g Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Cl바카라 시스템 배팅ical Practice Guidel바카라 시스템 배팅e for the Management of Glomerular Diseases.