1xbet 우회 Pharmaceutical, Co. Ltd.

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce 1xbet 우회 filing of a Biologics License Application (BLA) with 1xbet 우회 U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits 1xbet 우회 activity of APRIL (A PRoliferation-Induc1xbet 우회gLigand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in 1xbet 우회 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting 1xbet 우회 production of pathogenic Gd-IgA1 and immune complex formation. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients 1xbet 우회 option of convenience at home.

IgAN is a progressive, autoimmune, chronic kidney disease that is associated with a high risk for progression to end-stage kidney disease (ESKD) over 1xbet 우회 lifetime of many patients.¹ In 2024, 1xbet 우회 FDA granted aBreakthrough 1xbet 우회rapy designationfor sibeprenlimab following favorable results of 1xbet 우회 Phase 2 ENVISION clinical trial.² This designation accelerates 1xbet 우회 development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. If approved, sibeprenlimab would be administered via injection every four weeks, which would allow patients 1xbet 우회 convenience and option of self-administration in 1xbet 우회 home setting.³

1xbet 우회 BLA submission, Otsuka's first, is supported by results from 1xbet 우회 Phase 2 ENVISION clinical trial (NCT04287985) and 1xbet 우회 Phase 3 VISIONARY clinical trial (NCT05248646), which met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment.⁴In 1xbet 우회 trial, 1xbet 우회 safety profile of sibeprenlimab was favorable and consistent with previously reported data.

"This BLA filing marks an important milestone in Otsuka's commitment to address unmet needs in kidney diseases," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Sibeprenlimab's unique mechanism of action inhibits 1xbet 우회 activity of APRIL and addresses an IgA-specific driver of kidney loss in IgA nephropathy. APRIL is a cytokine that plays a key role in 1xbet 우회 pathogenesis of IgA nephropathy and we are optimistic about its potential to be an important treatment option for this progressive kidney disease. On behalf of Otsuka, we are grateful to every patient, caregiver and healthcare professional who has contributed so much to advancing this important research."

1xbet 우회 VISIONARY study is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 530 adult patients (largest trial to date) with IgA nephropathy who were receiving standard-of-care 1xbet 우회rapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate 1xbet 우회 efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo. 1xbet 우회 primary efficacy endpoint is to evaluate 1xbet 우회 change in 24-hour uPCR at 9 months compared with baseline.⁴ 1xbet 우회 secondary endpoint is to evaluate 1xbet 우회 annualized slope of eGFR estimated over ~24 months.⁴

"This BLA for sibeprenlimab represents a significant achievement in our journey to bring innovative treatments to patients with IgA nephropathy," commented Brian Pereira, M.D., CEO of Visterra, Inc., 1xbet 우회 U.S. affiliate of Otsuka that designed and engineered sibeprenlimab. "We look forward to 1xbet 우회 FDA's review and are grateful for 1xbet 우회 opportunity to help develop a treatment that could alter 1xbet 우회 course of this challenging kidney disease and improve patient outcomes."

About Sibeprenlimab
Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary 1xbet 우회 Otsuka. Pre-clinical and early-stage trials 1xbet 우회 sibeprenlimab were also conducted by Visterra.

Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits 1xbet 우회 activity of APRIL and plays a key role in 1xbet 우회 4-hit process. By binding and inhibiting APRIL, sibeprenlimab may help reduce 1xbet 우회 amount of immunoglobulin A (IgA) and Gd-IgA1 levels. Lower levels of Gd-IgA1 provide less substrate for immune complex formation, and may also result in reduced auto-antibody production. Decreased immune complex creation should result in diminished deposition in 1xbet 우회 kidney, and reduced proteinuria and kidney inflammation. By reducing 1xbet 우회 production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD.^2,4,5,6By inhibiting APRIL, sibeprenlimab may help address one of 1xbet 우회 IgA nephropathy-specific drivers for nephron loss.

About Immunoglobul1xbet 우회 A Nephropathy and APRIL
IgA nephropathy is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over 1xbet 우회 lifetime of most patients.^1,7,8

IgA nephropathy is characterized by 1xbet 우회 accumulation of Gd-IgA1 complexes in 1xbet 우회 kidneys. IgA nephropathy can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients.⁷Despite supportive care, 1xbet 우회re is an unmet need for treatments that address 1xbet 우회 root cause of 1xbet 우회 condition. Continued research in 1xbet 우회 disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients.⁹

APRIL, a cytokine in 1xbet 우회 tumor necrosis factor (TNF) family, is integral to 1xbet 우회 pathogenesis and progression of IgA nephropathy. It promotes 1xbet 우회 survival and class switching of B cells to produce IgA, particularly 1xbet 우회 pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in 1xbet 우회 kidneys.⁹

References

1. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of 1xbet 우회 American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/.

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

3. Otsuka Pharmaceutical Development & Commercialization, Inc., Sibeprenlimab Prefilled Syringe for 1xbet 우회 Treatment of IgA Nephropathy. Human Factors Formative 1 Study Report for Commercial Development Phase.

4. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial 1xbet 우회 Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov.

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

6. Chang S, Li XK. 1xbet 우회 Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov)

7. Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management 1xbet 우회 IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27.

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

9. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. 1xbet 우회 role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted 1xbet 우회rapies. Frontiers in nephrology. February 1, 2024.