[Translation] A Phase I, open-label, randomized, parallel-group clinical study to evaluate the pharmacokinetic characteristics, safety, tolerability, and immunogenicity of BION-1301 after a single dose in healthy adult Chinese subjects

主要目的：评估中国健康成年受试者单次皮下注射（SC）BION-1301的药代动力学（PK）特征次要目的：评估中国健康成年受试者单次SC BION-1301后对免疫球蛋白的药效学（PD）影响；评估中国健康成年受试者单次SC BION-1301的免疫原性；评估中国健康成年受试者单次SC BION-1301的安全性和耐受性

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous (SC) injection of BION-1301 in healthy Chinese adult subjects Secondary objectives: To evaluate the pharmacodynamic (PD) effects of a single SC BION-1301 on immunoglobulins in healthy Chinese adult subjects; To evaluate the immunogenicity of a single SC BION-1301 in healthy Chinese adult subjects; To evaluate the safety and tolerability of a single SC BION-1301 in healthy Chinese adult subjects

Start Date17 Apr 2023

Sponsor / Collaborator

Chinook Therapeutics, Inc.

[+3]

100 Clinical Results associated with Zigakibart

100 Translational Medicine associated with Zigakibart

100 Patents (Medical) associated with Zigakibart

Literatures (Medical) associated with Zigakibart

01 May 2024·DRUGS

Drugs in Development to Treat IgA Nephropathy

Review

Author: Del Vecchio, Lucia ; Comolli, Stefania ; Allinovi, Marco ; Locatelli, Francesco ; Rimoldi, Chiara ; Peiti, Silvia

IgA nephropathy is a common glomerulonephritis consequent to the autoimmune response to aberrant glycosylated immunoglobulin (Ig) A antibodies. Although it has historically been considered a benign disease, it has since become clear that a substantial percentage of patients reach end-stage kidney failure over the years. Several therapeutic attempts have been proposed, with systemic steroids being the most prevalent, albeit burdened by possible serious adverse events. Thanks to the more in-depth knowledge of the pathogenesis of IgA nephropathy, new treatment targets have been identified and new drugs developed. In this narrative review, we summarise the molecules under clinical development for the treatment of IgA nephropathy. As a search strategy, we used PubMed, Google, ClinicalTrials.gov and abstracts from recent international congresses. TRF budesonide and sparsentan are the two molecules at a more advanced stage, just entering the market. Other promising agents are undergoing phase III clinical development. These include anti-APRIL and anti-BLyS/BAFF antibodies and some complement inhibitors. Other new possible strategies include spleen tyrosine kinase inhibitors, anti-CD40 ligands and anti-CD38 antibodies. In an era increasingly characterised by 'personalised medicine' and 'precision therapy' approaches and considering that the potential therapeutic armamentarium for IgA nephropathy will be very broad in the near future, the identification of biomarkers capable of helping the nephrologist to select the right drug for the right patient should be the focus of future studies.

04 Dec 2023·Clinical kidney journal

The contribution of a proliferation-inducing ligand (APRIL) and other TNF superfamily members in pathogenesis and progression of IgA nephropathy

Review

Author: Barratt, Jonathan ; Yeo, See Cheng

ABSTRACT:

Advances in our understanding of the pathogenesis of immunoglobulin A nephropathy (IgAN) have led to the identification of novel therapeutic targets and potential disease-specific treatments. Specifically, a proliferation-inducing ligand (APRIL) has been implicated in the pathogenesis of IgAN, mediating B-cell dysregulation and overproduction of pathogenic galactose-deficient IgA1 (Gd-IgA1). Animal and clinical studies support the involvement of APRIL in the pathogenesis and progression of IgAN. An elevated level of APRIL is found in IgAN when compared with controls, which correlates with the level of Gd-IgA1 and associates with more severe disease presentation and worse outcomes. Conversely, anti-APRIL therapy reduces pathogenic Gd-IgA1 and IgA immune complex formation and ameliorates the severity of kidney inflammation and injury. Genome-wide association studies in IgAN have identified TNFSF13 and TNFRSF13B, a cytokine ligand-receptor gene pair encoding APRIL and its receptor, respectively, as risk susceptibility loci in IgAN, further supporting the causal role of the APRIL signalling pathway in IgAN. Several novel experimental agents targeting APRIL, including atacicept, telitacicept, zigakibart and sibeprenlimab, are currently under investigation as potential therapies in IgAN. Preliminary results suggest that these agents are well-tolerated, and reduce levels of Gd-IgA1, with corresponding improvement in proteinuria. Further studies are ongoing to confirm the safety and efficacy of anti-APRIL approaches as an effective therapeutic strategy in IgAN.

01 Dec 2023·Clinical rheumatology

A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP)

Review

Author: Lamond, Megan ; Chetwynd, Andrew J ; Marro, Julien ; Oni, Louise ; Williams, Chloe E C

Abstract:

Immunoglobulin A (IgA) vasculitis (IgAV, also known as Henoch-Schoenlein purpura, HSP) is the most common vasculitis of childhood. It usually presents with a simple, self-limiting disease course; however, a small subset of patients may develop kidney involvement (IgAV-N) which occurs 4–12 weeks after disease onset and is the biggest contributor to long-term morbidity. Treatment currently targets patients with established kidney involvement; however; there is a desire to work towards early prevention of inflammation during the window of opportunity between disease presentation and onset of significant nephritis. There are no clinical trials evaluating drugs which may prevent or halt the progression of nephritis in children with IgAV apart from the early use of corticosteroids which have no benefit. This article summarises the latest scientific evidence and clinical trials that support potential therapeutic targets for IgAV-N that are currently being developed based on the evolving understanding of the pathophysiology of IgAV-N. These span the mucosal immunity, B-cell and T-cell modulation, RAAS inhibition, and regulation of complement pathways, amongst others. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Further clinical trials, as well as pre-clinical scientific studies, are needed to identify mechanistic pathways as there may be an opportunity to prevent nephritis in this condition.Key Points• Kidney involvement is the main cause of long-term morbidity and mortality in IgA vasculitis despite the current treatment recommendations.• The evolving understanding of the pathophysiology of IgA vasculitis is allowing exploration of novel treatment options which target underlying immune pathways.• Novel treatments currently being trialled in IgA nephropathy may have benefit in IgA vasculitis due to the similarities in the underlying pathophysiology, such as TRF-budesonide, B-cell modulators, and complement inhibitors.• Further studies, including clinical trials of novel drugs, are urgently needed to improve the long-term outcomes for children with IgA vasculitis nephritis.

109

News (Medical) associated with Zigakibart

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/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/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/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary.wiley.com/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/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/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/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary.wiley.com/doi/full/10.1111/nep.13592 .

Phase 2Phase 3Breakthrough Therapy

31 Oct 2024

·endpts.com

Q&A: Jade CEO talks about reverse merger and IgAN drugs

This week, biotech builder Paragon Therapeutics took two of its portfolio companies public through reverse mergers — Crescent Biopharma and now Jade Biosciences . Four of the antibody maker’s five offshoots have now taken that path. Jade plans to start testing its IgA nephropathy drug JADE-001 — an anti-APRIL monoclonal antibody that can potentially be dosed every eight weeks — in healthy volunteers in the second half of 2025, CEO Tom Frohlich told Endpoints News . Otsuka and Novartis-acquired Chinook also have anti-APRIL programs. Frohlich declined to disclose details of Jade’s two other preclinical antibodies. “When Paragon announces a target, there’s a lot of competitors [that] pop out of the woodwork,” he said, speaking to Endpoints about the company’s latest move. This interview has been substantially edited for length and clarity. LaHucik: There’s been a few recent IgAN approvals , some Phase 3 successes, some acquisitions and some large financings . Frohlich: IgAN is an extremely exciting area, and the FDA’s willingness to use surrogate endpoints in this disease has really spurred a lot of innovation. All of the approved therapies, none of them actually treat that root cause of disease. That’s ACE inhibitors, corticosteroids, the endothelial antagonists, complement [inhibitors]. They all preserve nephron function, but they’re not attacking that root cause. We believe APRIL, which has proven to lower that pathogenic IgA in early clinical trials, will become the predominantly-used class within IgA nephropathy. LaHucik: You and a lot of the leadership team comes from Novartis-acquired Chinook . Novartis just did another deal with Versant to create Borealis , taking some people from that Chinook team. Did any of you consider joining that team, or what appealed you all to Jade? Frohlich: Borealis is a very exciting company. I’m actually on the board there. It’s looking at very early research and building a platform technology around RNA interference targeted to the kidney. Our team is much more focused on development. LaHucik: Why this route to the public markets, and why so quickly? (Jade emerged in August .) Frohlich: There’s a lot of demand right now for these types of companies. Raising this $300 million to date really allows us to focus on our programs and advance them at pace. LaHucik: What types of companies? Frohlich: Companies that have programs with high probability of success in the clinic and the opportunity to quickly accelerate through clinical development. LaHucik: Was there ever any thought of going the IPO route? Frohlich: We considered a number of options. But this is something that we could expedite. Our team is fairly impatient to get these programs to patients, and this proved to be a very fast transaction. LaHucik: Some Paragon companies have talked about their antibodies being similar to ones already in development or on the market. Talk about the technology. Frohlich: JADE-001 was actually created with a de novo screen so they are novel CDRs [complementarity-determining regions]. They were selected for high-binding affinity. We were looking for extremely potent compounds so we had the opportunity to inhibit APRIL completely throughout the dosing period.

AcquisitionPhase 3

100 Deals associated with Zigakibart

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	Phase 3	CN	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	JP	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	AR	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	AU	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	BE	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	BR	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	CA	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	HR	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	CZ	Chinook Therapeutics, Inc.	27 Jul 2023
Glomerulonephritis, IGA	Phase 3	FR	Chinook Therapeutics, Inc.	27 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03945318 (ADU-CL-19, ISN WCN2023)	Phase 1/2	Glomerulonephritis, IGA APRIL \| IgA \| Gd-IgA1 ... View more	-	BION-1301 450 mg IV	tdopcsqsxh(shfmfaytjz) = qtzehswhbn jgatkhetgk (hqnizdtaly )	Positive	01 Mar 2023
				BION-1301 600 mg SC	tdopcsqsxh(shfmfaytjz) = autyzttmgi jgatkhetgk (hqnizdtaly )
NCT03945318 (Phase 1/2 Study of BION-1301, ASN2022)	Phase 1/2	Glomerulonephritis, IGA APRIL \| IgA \| Gd-IgA1 ... View more	20	BION-1301 450 mg IV	guwdtckxtp(mekmebriwc) = bnquheyzjl ijqdsjntwu (jexbzrpcqy )	Positive	04 Nov 2022
				BION-1301 600 mg SC	guwdtckxtp(mekmebriwc) = smjkxlyklz ijqdsjntwu (jexbzrpcqy )
NCT03945318 (Corporate Publications) Manual	Phase 1/2	Glomerulonephritis, IGA	40	BION-1301 (450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖)	lozszphtfe(winjarrlbx) = hcstptmcfc rcatlqxmmu (ihrgmyosbf ) View more	Positive	01 Nov 2022
				BION-1301 (600 mg Q2W de novo SC, up to 104 weeks)	lozszphtfe(nwumrilnls) = ioatfksspy quvmkwcpsg (tidbkgibsc )
NCT03945318 (Corporate Publications) Manual	Phase 1/2	Glomerulonephritis, IGA	10	BION-1301	wjcjwrlbhb(dfvpblmejb) = uuvodqzgwd roskvctwgj (nntwduoacq ) View more	Positive	04 Nov 2021
NCT03340883 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Refractory Multiple Myeloma	21	BION-1301 (BION-1301 50 mg Q2W)	eqasfowsqu(iywxginyht) = sksibsnrvh hqkbzodheh (hkztegrijd, ifbmxsjqky - veakyrddzq) View more	-	07 Sep 2020
				BION-1301 (BION-1301 150 mg Q2W)	eqasfowsqu(iywxginyht) = puehaewbix hqkbzodheh (hkztegrijd, vjplmqgkyl - vaasoiocct) View more
NCT03340883 (ASCO2019) Manual	Phase 1	Refractory Multiple Myeloma	15	Zigakibart	fsllyfczuc(ihfmkwcqrz) = none zxupmxshqd (ytppwafdft ) View more	Negative	03 Jun 2019
BION-1301 (ASN2018)	Not Applicable	Glomerulonephritis, IGA APRIL \| BCMA \| TACI	-	BION-1301	yjthjqpczx(belceyfbbn) = zrlcshghvr ygwehtrhvq (jrdmeizdfj, 0.89) View more	Positive	23 Oct 2018

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Zigakibart

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation