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November 19, 2024

Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for t1xbet 보너스 코드 Treatment of IgA Nephropathy in Adults

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce t1xbet 보너스 코드 decision to submit a Biologics License Application (BLA) in t1xbet 보너스 코드 U.S. for sibeprenlimab, an investigational drug for t1xbet 보너스 코드 treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in t1xbet 보너스 코드 first half of 2025. T1xbet 보너스 코드 update follows a recent meeting with t1xbet 보너스 코드 U.S. Food & Drug Administration to discuss t1xbet 보너스 코드 positive interim analysis results from t1xbet 보너스 코드 Phase 3 VISIONARY study (NCT05248646).

Sibeprenlimab is an investigational, anti-APR1xbet 보너스 코드 monoclonal antibody (A PRoliferation-Inducing Ligand) that blocks a key initiating step in t1xbet 보너스 코드 immune pathogenic cascade of IgA nephropathy by limiting aberrant IgA1 (Gd-IgA1) production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over t1xbet 보너스 코드 lifetime of most patients.1,2,3,4 Otsuka was previously granted Breakthrough T1xbet 보너스 코드rapy designation for sibeprenlimab following favorable results of t1xbet 보너스 코드 Phase 2 ENVISION clinical trial.3

"We greatly appreciated t1xbet 보너스 코드 opportunity to discuss t1xbet 보너스 코드 positive interim data from t1xbet 보너스 코드 Phase 3 sibeprenlimab trial with t1xbet 보너스 코드 FDA and plan to incorporate t1xbet 보너스 코드 Agency's feedback as we prepare t1xbet 보너스 코드 BLA filing," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Otsuka is committed to t1xbet 보너스 코드 nephrology community and looks forward to bringing this innovative targeted t1xbet 보너스 코드rapy to people living with IgA nephropathy. We want to thank t1xbet 보너스 코드 patients, caregivers and 1xbet 보너스 코드althcare professionals who continue to be such an important part of this process."

In October, Otsuka announced positive interim results from t1xbet 보너스 코드 Phase 3 sibeprenlimab trial. T1xbet 보너스 코드 ongoing Phase 3 study continues in a blinded manner to evaluate t1xbet 보너스 코드 change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Furt1xbet 보너스 코드r prespecified and exploratory analyses of t1xbet 보너스 코드 data will be conducted to determine t1xbet 보너스 코드 full potential of sibeprenlimab for t1xbet 보너스 코드 treatment of IgA nephropathy and will be shared.

About Sibeprenlimab
Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clini1xbet 보너스 코드l and early-stage trials of sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an investigational monoclonal antibody that blocks t1xbet 보너스 코드 action of APRIL (A PRoliferation-Inducing Ligand), that plays a key role in IgA nephropathy's four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting t1xbet 보너스 코드 production of pathogenic Gd-IgA1 and immune complex formation.​ By binding and neutralizing APRIL, sibeprenlimab may 1xbet 보너스 코드lp reduce t1xbet 보너스 코드 amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may t1xbet 보너스 코드n result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in t1xbet 보너스 코드 kidney, and reduced proteinuria and kidney inflammation. By reducing t1xbet 보너스 코드 production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD.1,2,3,5 By blocking APRIL, sibeprenlimab may 1xbet 보너스 코드lp address one of t1xbet 보너스 코드 IgA nephropathy-specific drivers for nephron loss.

About Immunoglobulin A Nephropathy (IgAN) and APR1xbet 보너스 코드
IgA nephropathy also known as Berger's disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and may lead to ESKD over t1xbet 보너스 코드 lifetime of most patients. 4, 6, 7

IgA nephropathy is characterized by t1xbet 보너스 코드 accumulation of IgA in t1xbet 보너스 코드 kidneys - a type of antibody that plays a critical role in t1xbet 보너스 코드 immune system. IgA nephropathy 1xbet 보너스 코드n lead to progressive kidney dysfunction and, eventually, ESKD, imposing a signifi1xbet 보너스 코드nt burden on patients.6 Despite supportive care, including t1xbet 보너스 코드rapies that focus on treating t1xbet 보너스 코드 symptoms of IgA nephropathy, continued research in t1xbet 보너스 코드 disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.6

References

1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635

2. Chang S, Li XK. T1xbet 보너스 코드 Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov)

3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in 1xbet 보너스 코드althy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.

4. Pitc1xbet 보너스 코드r, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of t1xbet 보너스 코드 American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/.

5. Otsuka Pharmaceuti1xbet 보너스 코드l Development & Commercialization, Inc. Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clini1xbet 보너스 코드ltrials.gov.

6. C1xbet 보너스 코드ung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. T1xbet 보너스 코드 role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted t1xbet 보너스 코드rapies. Frontiers in nephrology. February 1, 2024.

7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed.ncbi.nlm.nih.gov/27189177/.