Delving into the Latest Updates on Vunakizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

+ [1]

Target

IL-17A

Mechanism

IL-17A inhibitors(Interleukin 17A inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesInfectious Diseases+ [4]

Active Indication

Plaque psoriasisAnkylosing SpondylitisArthritis, Psoriatic+ [2]

Inactive Indication

Axial Spondyloarthritis

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Inactive Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.Atridia Pty Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (20 Aug 2024),

Plaque psoriasis

Regulation-

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Gene Sequence

Sequence Code 319922230L

Source: *****

Sequence Code 319922229H

Source: *****

主要目的：评价SHR-1314 注射液(以下简称SHR-1314)皮下给药在成人活动性银屑病关节炎(PsA)患者中的有效性(美国风湿病学会定义的 20%改善[ACR 20]与安慰剂相比)。次要目的：评价SHR-1314治疗成人活动性银屑病关节炎受试者的其他有效指标、安全性、免疫原性和药代动力学。

[Translation]

Primary objective: To evaluate the efficacy of subcutaneous administration of SHR-1314 injection (hereafter referred to as SHR-1314) in adult patients with active psoriatic arthritis (PsA) (20% improvement [ACR 20] as defined by the American College of Rheumatology compared with placebo). Secondary objective: To evaluate other efficacy indicators, safety, immunogenicity, and pharmacokinetics of SHR-1314 in the treatment of adult subjects with active psoriatic arthritis.

Start Date04 Nov 2024

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

NCT06640257 / RecruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.

Start Date04 Nov 2024

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

NCT06182384 / CompletedPhase 1

A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.

Start Date24 Dec 2023

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Vunakizumab

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100 Translational Medicine associated with Vunakizumab

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100 Patents (Medical) associated with Vunakizumab

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5

Literatures (Medical) associated with Vunakizumab

01 Sep 2024·Journal of the American Academy of Dermatology

Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial

Article

Author: Li, Yanling ; Li, Xin ; Ji, Chao ; Chen, Aijun ; Zhang, Litao ; Han, Xiuping ; Wang, Wenqin ; Yan, Kexiang ; Li, Linfeng ; Wang, Xiaohua ; Wang, Yu ; Lu, Jianyun ; Han, Ling ; Li, Yanlin ; Li, Fuqiu ; Jiang, Meiying ; Zhang, Siping ; Lu, Yan ; Xu, Jinhua ; Zhang, Zhenghua ; Bi, Xiaodong ; Xu, Ai'e ; Yao, Xiaoyan ; Cui, Xiaojing ; Liu, Donghua ; Sun, Jianfang ; Li, Shanshan ; Cheng, Hao ; Wang, Wenqing ; Dong, Guangchao ; Chen, Rixin ; Li, Hongyi ; Zhu, Xiaohong ; Li, Zhiming ; Li, Yuye ; Bai, Xiaoyan ; Mou, Kuanhou ; Zhang, Chunlei ; Yang, Sen ; Meng, Zudong

BACKGROUNDVunakizumab, a novel anti-interleukin-17A antibody, has shown promising efficacy for moderate-to-severe plaque psoriasis in a phase 2 trial.OBJECTIVEWe conducted a double-blind, randomized phase 3 trial (NCT04839016) to further evaluate vunakizumab in this population.METHODSSix hundred ninety subjects were randomized (2:1) to receive vunakizumab 240 mg or placebo at weeks 0, 2, 4, and 8. At week 12, subjects on placebo were switched to vunakizumab 240 mg (weeks 12, 14, 16, and every 4 weeks thereafter). The co-primary endpoints were ≥90% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 90) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.RESULTSAt week 12, the vunakizumab group showed higher PASI 90 (76.8% vs 0.9%) and sPGA 0/1 (71.8% vs 0.4%) response rates, as well as higher PASI 75 (93.6% vs 4.0%), PASI 100 (36.6% vs 0.0%), and sPGA 0 (38.2% vs 0.0%) response rates (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 with continuous vunakizumab. Possible treatment-related serious adverse events occurred in 0.9% of vunakizumab-treated subjects.LIMITATIONSChinese subjects only; no active comparator.CONCLUSIONVunakizumab demonstrated robust clinical response at week 12 and through week 52, with good tolerability in moderate-to-severe plaque psoriasis.

01 Jul 2022·Journal of the American Academy of DermatologyQ1 · MEDICINE

A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis

Q1 · MEDICINE

Article

Author: Xu, Qian ; Wu, Jianhua ; Yang, Sen ; Zhang, Chunlei ; Diao, Qingchun ; Xu, Jinhua ; Sinclair, Rodney ; Chen, Xiang ; Guo, Qing ; Yu, Hong ; Lei, Tiechi ; Jin, Hongzhong ; Zhu, Yi ; Yan, Kexiang ; Zheng, Min ; Gao, Xinghua

BACKGROUNDVunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.OBJECTIVETo evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.METHODSIn this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.RESULTSAt week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.LIMITATIONSThe study was relatively short in duration and included no active control.CONCLUSIONVunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.

Frontiers in ImmunologyQ2 · MEDICINE

A Novel Bifunctional Fusion Protein, Vunakizumab-IL22, for Protection Against Pulmonary Immune Injury Caused by Influenza Virus

Q2 · MEDICINE

ArticleOA

Author: Zeng, Xian ; Cen, Lifeng ; Zhu, Haiyan ; Mei, Xiaobin ; Ju, Dianwen ; Fan, Jiajun ; Shi, Chenchen ; Han, Lei

Influenza A virus infection is usually associated with acute lung injury, which is typically characterized by tracheal mucosal barrier damage and an interleukin 17A (IL-17A)-mediated inflammatory response in lung tissues. Although targeting IL-17A has been proven to be beneficial for attenuating inflammation around lung cells, it still has a limited effect on pulmonary tissue recovery after influenza A virus infection. In this research, interleukin 22 (IL-22), a cytokine involved in the repair of the pulmonary mucosal barrier, was fused to the C-terminus of the anti-IL-17A antibody vunakizumab to endow the antibody with a tissue recovery function. The vunakizumab-IL22 (vmab-IL-22) fusion protein exhibits favorable stability and retains the biological activities of both the anti-IL-17A antibody and IL-22 in vitro. Mice infected with lethal H1N1 influenza A virus and treated with vmab-mIL22 showed attenuation of lung index scores and edema when compared to those of mice treated with saline or vmab or mIL22 alone. Our results also illustrate that vmab-mIL22 triggers the upregulation of MUC2 and ZO1, as well as the modulation of cytokines such as IL-1β, HMGB1 and IL-10, indicating the recovery of pulmonary goblet cells and the suppression of excessive inflammation in mice after influenza A virus infection. Moreover, transcriptome profiling analysis suggest the downregulation of fibrosis-related genes and signaling pathways, including genes related to focal adhesion, the inflammatory response pathway, the TGF-β signaling pathway and lung fibrosis upon vmab-mIL22 treatment, which indicates that the probable mechanism of vmab-mIL22 in ameliorating H1N1 influenza A-induced lung injury. Our results reveal that the bifunctional fusion protein vmab-mIL22 can trigger potent therapeutic effects in H1N1-infected mice by enhancing lung tissue recovery and inhibiting pulmonary inflammation, which highlights a potential approach for treating influenza A virus infection by targeting IL-17A and IL-22 simultaneously.

100 Deals associated with Vunakizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15154

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	CN	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	20 Aug 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	NDA/BLA	CN	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	08 Feb 2024
Arthritis, Psoriatic	Phase 3	CN	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	04 Nov 2024
Graves Ophthalmopathy	Phase 2	-	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	13 Jun 2022
Lupus Nephritis	Phase 2	CN	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	08 Jun 2021
Plaque psoriasis	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	25 Apr 2021
Axial Spondyloarthritis	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	19 Apr 2018
Psoriasis	Phase 2	AU	Atridia Pty Ltd.	22 Aug 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04840485 (EULAR2024) Manual	Phase 2/3	Ankylosing Spondylitis	548	Vunakizumab 120 mg	(wjmcnwgvvu) = wkhaugbwpw zrfvymrqpr (agbeyaizhn ) View more	Positive	14 Jun 2024
				Placebo	(wjmcnwgvvu) = gcutdxpkst zrfvymrqpr (agbeyaizhn ) View more
NCT04840485 (SHR-1314-302, Corporate Publications) Manual	Phase 2/3	Ankylosing Spondylitis	548	SHR-1314	(hwohavyehw) = 与安慰剂相比，SHR-1314对活动性强直性脊柱炎具有统计学显著性和临床意义的改善。 cqtlnlowak (omnekadvbt ) Met View more	Positive	18 Feb 2024
				安慰剂
NCT04839016 (EADV2023) Manual	Phase 3	Plaque psoriasis	690	Vunakizumab 240 mg	(nbattctvsy) = zlccrmoilr uuvdkkcxhd (qvnythbzrr, 72.7 - 80.5) Met View more	Positive	11 Oct 2023
				Placebo	(nbattctvsy) = xkbdmoknlf uuvdkkcxhd (qvnythbzrr, 0.2 - 3.1) Met View more
NCT03463187 (Pubmed \| J Am Acad Dermatol)	Phase 2	Plaque psoriasis	187	Vunakizumab 40 mg	(rnjkmnhtkq) = megdlvehep hihowxtknw (kplukchjlh )	Positive	10 Jan 2022
				Vunakizumab 80 mg	(rnjkmnhtkq) = ebupyctelk hihowxtknw (kplukchjlh )