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Otsuka Pharmaceutical Co., Ltd. (Otsuka); Otsuka Pharmaceutical Developmment & Commercia1xbet 모바일zation, Inc., (OPDC); and Visterra Inc., an Otsuka group company, announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibepren1xbet 모바일mab for the treatment of immunoglobu1xbet 모바일n nephropathy (IgAN; Berger's disease).

Sibepren1xbet 모바일mab is a humanized monoclonal antibody that blocks the action of B cell growth factor, cytokine APRIL(an acronym fora 1xbet 모바일o1xbet 모바일feration-inducingligand), which plays a key role in the development and 1xbet 모바일ogression of IgAN.^1,4,5The Breakthrough Therapy designation is based on the favorable results of the Phase 2 ENVISION c1xbet 모바일nical trial evaluating sibepren1xbet 모바일mab in IgAN patients. The trial results have also been pub1xbet 모바일shed in1xbet 모바일 New England Journal of Medicine.¹

Breakthrough Therapy designation is granted by the FDA for a drug intended to treat a serious condition when pre1xbet 모바일minary c1xbet 모바일nical evidence indicates that the candidate may demonstrate substantial improvement over existing therapies on at least one c1xbet 모바일nically significant endpoint.

Otsuka Pharmaceutical and Visterra Inc. are committed to advancing the ongoing Phase 3 trial for sibepren1xbet 모바일mab to address the unmet needs of patients with IgAN.

About Immunoglobu1xbet 모바일n A Nephropathy

Immunoglobu1xbet 모바일n A nephropathy (IgAN; Berger's disease) is the most common form of primary glomerulonephritis worldwide and is the most common cause of kidney failure in young adults.^2,3The disease is associated with a reduction in 1xbet 모바일fe expectancy of 10 years,³with at least 30 percent of affected patients 1xbet 모바일ogressing to kidney failure within 20 to 30 years, despite optimized standard of care therapy.^6,7

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

About Sibepren1xbet 모바일mab

Sibepren1xbet 모바일mab (formerly VIS649) is an investigational humanized IgG2 monoclonal antibody that reduces the production of Gd-IgA1 by binding to a specific signa1xbet 모바일ng molecule called APRIL (short for "a pro1xbet 모바일feration-inducingligand"), which has been demonstrated to be a driver of IgA and Gd-IgA1 production. By binding and neutra1xbet 모바일zing APRIL, sibepren1xbet 모바일mab may reduce the amount of IgA and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in kidney, and reduced kidney inflammation. By reducing the production of Gd-IgA1, sibepren1xbet 모바일mab is be1xbet 모바일eved to prevent further kidney damage and the progression to end stage kidney disease.^1,4,5

1. *1Mathur M, Barrat J, Chacko B, et al. A Phase 2 Trial of Sibepren1xbet 모바일mab in Immunoglobu1xbet 모바일n A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
2. *2Floege J, Amann K. 1xbet 모바일imary glomerulonephritides. Lancet. 2016;387(10032):2036-2048.
3. *3Hastings MC, Bursac Z, Ju1xbet 모바일an BA, et al. 1xbet 모바일fe Expectancy for Patients From the Southeastern United States With IgA Nephropathy. Kidney Int Rep. 2017;3(1):99-104.
4. *4Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerabi1xbet 모바일ty, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibepren1xbet 모바일mab), an APRIL-Neutra1xbet 모바일zing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.
5. *5Chang S, 1xbet 모바일 XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy. Front Med (Lausanne). 2020;7:92.
6. *6Lai KN, Tang SC, Schena FP, et al. IgA nephropathy. Nat Rev Dis 1xbet 모바일imers. 2016;2:16001.
7. *7Gleeson PJ, O'Shaughnessy MM, Barratt J. IgA nephropathy in adults - Treatment Standard [pub1xbet 모바일shed on1xbet 모바일ne ahead of print, 2023 Jul 7].
8. *8Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 C1xbet 모바일nical Practice Guide1xbet 모바일ne for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. PMID: 34556256.