A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Start Date19 Nov 2024

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

CTR20223141

/ RecruitingPhase 3

一项在免疫球蛋白A肾病受试者中评价Sibeprenlimab皮下给药的有效性和安全性的多中心、随机、双盲、安慰剂对照、III期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy and safety of subcutaneous sibeprenlimab in subjects with immunoglobulin A nephropathy

比较标准治疗附加Sibeprenlimab或安慰剂皮下给药9个月后uPCR较基线的相对变化。

[Translation]

The relative change from baseline in uPCR was compared after 9 months of subcutaneous administration of sibeprenlimab or placebo added to standard of care.

Start Date27 Mar 2023

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

[+3]

SLCTR/2022/028

/ CompletedPhase 2/3

Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

Start Date30 Nov 2022

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

100 Clinical Results associated with Sibeprenlimab

100 Translational Medicine associated with Sibeprenlimab

100 Patents (Medical) associated with Sibeprenlimab

Literatures (Medical) associated with Sibeprenlimab

01 Feb 2025·AGING MEDICINE

A novel agent targeting APRIL: A new hope for elderly patients of IgA nephropathy

Article

Author: Liu, Xin ; Zuo, Li

Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes the activity of APRIL. It should usher in a new era in the treatment of IgAN, especially in elderly patients.

01 Jan 2025·Revue Médicale Suisse

Néphrologie : ce qui a changé en 2024 (II)

Article

Author: Bourdon, Fanny ; De Seigneux, Sophie ; Haidar, Fadi ; Baldet, Kadiatou ; Jaques, David ; Saudan, Patrick

Certain molecules, such as GLP-1 agonists and endothelin antagonists, possess nephroprotective properties. When treating IgA nephropathy, endothelin antagonists and sibeprenlimab have shown effectiveness in slowing the progression of chronic kidney isease. Additionally, the infusion of amino acids can reduce the incidence of mild acute kidney injury following cardiac surgery. In hemodialysis, the sodium content in the dialysate appears to affect patient mortality rates. For individuals starting hemodialysis after the age of 75, there is a modest survival benefit, although it comes at the cost of reduced time spent at home. In the future, noninvasive biomarkers may enable early detection of renal graft rejection.

03 May 2024·Expert Opinion on Biological Therapy

Sibeprenlimab, which neutralizes A PRoliferation Inducing Ligand (APRIL), as a new approach to treating IgA nephropathy

Article

Author: Doggrell, Sheila A.

INTRODUCTIONImmunoglobulin A (IgA) nephropathy is a common immune-mediated kidney disease leading to high blood pressure and may progress to kidney failure. None of the present treatments are disease-modifying or prolong life. The levels of A PRoliferation Inducing Ligand (APRIL) are raised in subjects with IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to, and neutralizes, APRIL.AREAS COVEREDA phase 2 clinical trial of intravenous sibeprenlimab (VIS649) in IgA nephropathy: NCT04287985. The primary efficacy endpoint was the change from baseline in 24-h protein-to-creatinine ratio at 12 months, and this was reduced by sibeprenlimab. Sibeprenlimab also caused clinical remission in some subjects, stabilized estimated glomerular filtration rate (eGFR), and reduced galactose deficient IgA1, IgA, IgM, and IgG levels without causing any infections or other adverse events.EXPERT OPINIONSibeprenlimab is a promising new approach to treating IgA nephropathy. The pharmaceutical company behind sibeprenlimab is also developing it for subcutaneous use, which would have advantages over intravenous use. As IgA nephropathy is a long-term progressive disease, key questions that need to be answered, over a long-time course, with sibeprenlimab are (i) whether its safety is maintained, and (ii) whether it improves clinical outcomes.

News (Medical) associated with Sibeprenlimab

14 Jan 2025

·endpts.com

Biohaven’s protein degrader is promising in early IgAN trial, heads straight to Phase 3

Interim Phase 1 data on Biohaven’s protein degrader are strong enough that the biotech is planning to move the drug straight into pivotal trials in the kidney disease IgA nephropathy (IgAN). BHV-1400 is a next-gen protein degrader designed to break down galactose-deficient IgA1 (Gd-IgA1), the antibody that causes IgAN. Data from the first human trial of the product showed a median reduction in Gd-IgA1 levels of 60% within four hours of administration of a single 125 mg dose. Reduction of more than 70% was seen within eight hours, Biohaven said in a Tuesday release . Analysts from Cowen wrote in a same-day note that this was a “significantly more rapid and robust” reduction in Gd-IgA1 than the approximate 10% reduction seen with Vertex’s dual BAFF/APRIL antagonist povetacicept after four days, as well as the cut of around 60% achieved by Otsuka’s anti-APRIL agent sibeprenlimab after four weeks. Biohaven claims this reduction of Gd-IgA1 is “unprecedented” in drugs targeting this antibody, and could permit better safety compared with complement inhibition or broad antibody suppression. Safety has been clear so far in the Phase 1, with no clinically significant alterations in white blood cells or immunoglobulins IgG, IgA, IgE, and IgM, the biotech said. No-dose limiting toxicities were seen, and further dose escalation is planned. Biohaven said it is planning to start a pivotal Phase 3 trial in IgAN using an accelerated regulatory path, should BHV-1400 continue to be safe and show Gd-IgA1 reductions. Products including Calliditas Therapeutics’ Tarpeyo and Travere Therapeutics’ Filspari obtained accelerated approval for IgAN and then converted this into full approval. However, these do not act in the same way as BHV-1400. Biohaven also said that the lead indication for its IgG degrader BHV-1300, which reported early data from a multiple ascending dose Phase 1 study in December , would be Graves’ disease. Dosing of BHV-1300 in the Phase 1 trial is expected to conclude in the first half of this year, with a Phase 2 starting mid-year.

Phase 1Clinical ResultPhase 2Phase 3Accelerated Approval

19 Nov 2024

·pipelinereview.com

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

PRINCETON, NJ, USA & TOKYO, Japan I November 19, 2024 I Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646). Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the 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 the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 “We greatly appreciated the opportunity to discuss the positive interim data from the Phase 3 sibeprenlimab trial with the FDA and plan to incorporate the Agency’s feedback as we prepare the 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 the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare professionals who continue to be such an important part of this process.” In October, Otsuka announced positive interim results from the Phase 3 sibeprenlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the 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-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL (A PR oliferation- I nducing L igand), 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 the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (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 the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy (IgAN) and APRIL 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 the lifetime of most patients. 4, 6, 7 IgA nephropathy is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system.IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide . Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. 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.libproxy1.nus.edu.sg/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The 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 Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/full/10.1111/nep.13592 . SOURCE: Otsuka Pharmaceutical

Phase 2Phase 3Breakthrough Therapy

19 Nov 2024

·www.businesswire.com

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

PRINCETON, N.J. & TOKYO--( BUSINESS WIRE )--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646). Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the 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 the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 “We greatly appreciated the opportunity to discuss the positive interim data from the Phase 3 sibeprenlimab trial with the FDA and plan to incorporate the Agency's feedback as we prepare the 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 the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare professionals who continue to be such an important part of this process.” In October, Otsuka announced positive interim results from the Phase 3 sibeprenlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the 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-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL (A PR oliferation- I nducing L igand), 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 the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (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 the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy (IgAN) and APRIL 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 the lifetime of most patients. 4, 6, 7 IgA nephropathy is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system. IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide . Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. 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.libproxy1.nus.edu.sg/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The 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 Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/full/10.1111/nep.13592 .

Phase 2Phase 3Breakthrough Therapy

100 Deals associated with Sibeprenlimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	15 Mar 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04287985 (VIS649-201, CTgov)	Phase 2	Glomerulonephritis, IGA	155	Dose-Placebo	amirbjvjvn(youwezfzkn) = layvxzerxw zbbijeyhdc (ydatrqjved, sqisvjbxlp - rodefwhixj) View more	-	21 Nov 2024
NCT05248646 (VISIONARY, Company_Website) Manual	Phase 3	Glomerulonephritis, IGA	530	sibeprenlimab	(igskndvmtg) = sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment. amvtfowngj (gkrrkssjmm ) Met View more	Positive	22 Oct 2024
				Placebo
NCT04287985 (VIS649-201, Pubmed \| NEWS \| Br Dent J) Manual	Phase 2	Glomerulonephritis, IGA	155	sibeprenlimab	(jelpiqsvob) = mvftahxsob ernqdpmqsr (gdnhwwinpn, 8.2) View more	Positive	02 Nov 2023
				sibeprenlimab	(jelpiqsvob) = xpstffuboy ernqdpmqsr (gdnhwwinpn, 6.1) View more
NCT04287985 (VIS649-201, ISN WCN2023)	Phase 2	Glomerulonephritis, IGA Gd-IgA1 \| APRIL \| total IgA ... View more	72	Sibeprenlimab	uxhmufjimq(bfomnviarv) = gvlczuljqp nzbbndfnku (xibcfgjdjf, 11) View more	Positive	01 Mar 2023
NCT03719443 (ERA2021) Manual	Phase 1	Diphtheria \| Tetanus	14	VIS649	uvpuhzeqgj(tadsjlmxzn) = ctmbqsycom ololmovinu (vtqqvvhyba ) View more	Positive	17 Sep 2021
				Placebo	uvpuhzeqgj(tadsjlmxzn) = opmektdiud ololmovinu (vtqqvvhyba ) View more
NCT03719443 (VIS649, ASN2017)	Phase 1	Glomerulonephritis, IGA IgA \| IgG \| IgM	4	VIS649 25 mg/kg	rnhojdbhjs(budggqfbvl) = esgcdbwqxk kcxbomcrwf (dhygiiqcgb )	Positive	31 Oct 2017

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