乐维利单抗(Levilimab) - 药物靶点：IL-6RA_在研适应症：类风湿关节炎，新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Ilsira

靶点

IL-6RA

作用方式

拮抗剂

作用机制

IL-6RA拮抗剂(白细胞介素-6受体α亚基拮抗剂)

治疗领域

免疫系统疾病感染呼吸系统疾病+ [1]

在研适应症

类风湿关节炎新型冠状病毒感染

非在研适应症-

原研机构

Biocad Medical, Inc.

在研机构

Biocad CJSC

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2020-06-04),

新型冠状病毒感染

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 432066943L

来源: *****

Sequence Code 432066942H

来源: *****

关联

5

项与乐维利单抗相关的临床试验

NCT05800327

/ Active, not recruiting临床3期

A Two-Stage Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Various Doses of Levilimab When Administered Intravenously and Subcutaneously to Healthy Subjects and Subjects With Active Rheumatoid Arthritis

This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active rheumatoid arthritis resistant to methotrexate monotherapy.
Aim of the Stage 1 is to study the tolerability, safety, immunogenicity, and main pharmacokinetic and pharmacodynamic parameters of levilimab after its single subcutaneous or intravenous administration at ascending doses to healthy subjects.
Aim of the Stage 2 is to confirm the efficacy and safety of levilimab 648 mg IV Q4W in combination with methotrexate and levilimab 324 mg SC Q2W in combination with methotrexate in subjects with active rheumatoid arthritis, resistant to methotrexate monotherapy.

开始日期2022-12-07

申办/合作机构

Biocad CJSC

NCT04397562

/ Completed临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.

开始日期2020-04-29

申办/合作机构

Biocad CJSC

NCT04227366

/ Completed临床3期

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor.
The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

开始日期2019-11-19

申办/合作机构

Biocad CJSC

100 项与乐维利单抗相关的临床结果

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100 项与乐维利单抗相关的转化医学

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100 项与乐维利单抗相关的专利（医药）

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10

项与乐维利单抗相关的文献（医药）

2023-01-01·Annals of the Rheumatic Diseases

Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Review

作者: Edwards, Christopher John ; van der Heijde, Désirée ; de Souza, Savia ; Stamm, Tanja A ; Caporali, Roberto ; Verschueren, Patrick ; Schoones, Jan W ; Sepriano, Alexandre ; Smolen, Josef S ; Hyrich, Kimme L ; Aletaha, Daniel ; Winthrop, Kevin L ; Pope, Janet E ; Takeuchi, Tsutomu ; Kerschbaumer, Andreas ; Bergstra, Sytske Anne ; Landewé, Robert B M

ObjectivesTo update the evidence on efficacy of DMARDs (disease-modifying antirheumatic drugs) and inform the taskforce of the 2022 update of the European Alliance of Associations for Rheumatology (EULAR) recommendations for management of rheumatoid arthritis (RA).MethodsThis systematic literature review (SLR) investigated the efficacy of conventional synthetic (cs), biological (b), biosimilar and targeted synthetic (ts)DMARDs in patients with RA. Medline, EMBASE, Cochrane CENTRAL and Web of Science were used to identify all relevant articles published since the previous update in 2019 to 14 January 2022.ResultsOf 8969 search results, 169 articles were selected for detailed review and 47 were finally included. Trials investigated the efficacy of csDMARDs, bDMARDs and tsDMARDs, DMARD switching, tapering and trials investigating different treatment strategies. The compounds investigated were csDMARDs (methotrexate (MTX), leflunomide, sulfasalazine, hydroxychloroquine), bDMARDs (abatacept, adalimumab, certolizumab-pegol, denosumab, etanercept, infliximab, levilimab, olokizumab, opineracept, rituximab, sarilumab, tocilizumab) and tsDMARDs (baricitinib, filgotinib, tofacitinib, upadacitinib). The efficacy of csDMARDs+ short-term glucocorticoids in early RA was confirmed and similar to bDMARD+MTX combination therapy. Interleukin-6 pathway inhibition was effective in trials on olokizumab and levilimab. Janus kinase inhibitor (JAKi) was efficacious in different patient populations. After insufficient response to JAKi, patients could respond to TNFi treatment. Tapering of DMARDs was feasible for a proportion of patients, who were able to taper therapy while remaining in low disease activity or remission.ConclusionThe results of this SLR, together with one SLR on safety of DMARD and one on glucocorticoids, informed the taskforce of the 2022 update of the EULAR recommendations for pharmacological management of RA.

2021-12-01·Inflammation Research3区 · 医学

The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study

3区 · 医学

Article

作者: Gordeev, Ivan G ; Mazurov, Vadim I ; Pasechnik, Elena S ; Eremeeva, Anna V ; Dokukina, Ekaterina A ; Bakirov, Bulat A ; Lomakin, Nikita V ; Lutckii, Anton A ; Linkova, Yulia N ; Smolyarchuk, Elena A ; Fomina, Darya S ; Gilyarov, Mikhail Yu ; Seleznev, Anton I ; Morozova, Maria A ; Musaev, Gaziyavdibir H ; Moiseeva, Olga M ; Zinkina-Orikhan, Arina V ; Protsenko, Denis N ; Popov, Vladimir V ; Pukhtinskaia, Polina S

AbstractObjective and designThe aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.SubjectsThe study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.Treatment206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy.MethodsThe primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders.Results63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 (P = .0017). The frequency of adverse drug reactions was comparable between the groups.ConclusionIn patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate.Trail registrationThe trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).

2021-01-01·mAbs2区 · 医学

Antibodies to watch in 2021

2区 · 医学

Review

作者: Reichert, Janice M. ; Kaplon, Hélène

In this 12^th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.

1

项与乐维利单抗相关的新闻（医药）

2023-12-01

·SYNAPSE

Deciphering IL-6 Inhibitors: Your Guide to Rapidly Accessing the Newest Advances

IL-6, or Interleukin-6, is a cytokine that plays a crucial role in the human body's immune response and inflammation regulation. It is produced by various cells, including immune cells, and acts as a signaling molecule to stimulate the immune system during infection or injury. IL-6 also plays a role in the development and differentiation of immune cells, such as B cells and T cells. However, excessive or prolonged IL-6 production can lead to chronic inflammation and contribute to the pathogenesis of various diseases, including autoimmune disorders and certain cancers. Therefore, understanding and regulating IL-6 levels is of great importance in the pharmaceutical industry for the development of targeted therapies. IL-6 Inhibitors is relevant to many inflammatory diseases and cancers. The first approved medication in this class was tocilizumab (Actemra), an antibody directed against the IL-6 receptor. This was followed by siltuximab (Sylvant), which is directed against IL-6 itself. Sarilumab was approved by the US FDA in 2017 for rheumatoid arthritis. Several other agents are in clinical trials, including olokizumab (CDP6038), elsilimomab, clazakizumab (BMS-945429, ALD518), sirukumab (CNTO 136), levilimab (BCD-089), and CPSI-2364. Looking ahead, IL-6 inhibitors are expected to continue to play a significant role in the treatment of various diseases. They have shown promising results in treating serious COVID-19 cases2 and are also used widely for the treatment of rheumatoid arthritis2. The IL-6 inhibitors market is projected to grow at a CAGR of 10.9%, increasing from US$ 33.3 Billion in 2023 to US$ 93.3 Billion by 20333. However, the emergence of resistance and the lack of an effective reversal drug when bleeding occurs are challenges that need to be addressed. Ongoing research and development efforts are focused on addressing these issues and expanding the clinical applications of IL-6 inhibitors. Based on the analysis of the data, the current competitive landscape for target IL-6 is characterized by the presence of multiple companies with varying stages of development and a wide range of indications. Bristol Myers Squibb Co. stands out as the company with the highest stage of development, with multiple approved drugs and ongoing clinical trials. Small molecule drugs, molecular glues, and monoclonal antibodies are the most rapidly progressing drug types under the target IL-6. The United States, European Union, and China are the leading countries/locations in terms of development, with China showing significant progress. Overall, the target IL-6 presents a competitive landscape with diverse players and promising future development potential. How do they work?IL-6 inhibitors are a type of medication that target and inhibit the activity of interleukin-6 (IL-6), a cytokine involved in the immune response and inflammation. From a biomedical perspective, IL-6 inhibitors are used in the treatment of various inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, and Castleman's disease. These inhibitors work by blocking the binding of IL-6 to its receptor, thereby reducing the inflammatory response mediated by IL-6. By inhibiting IL-6, these medications help alleviate symptoms and reduce disease progression in patients with IL-6-mediated inflammatory disorders List of IL-6 InhibitorsThe currently marketed IL-6 inhibitors include: SiltuximabPomalidomidePirfenidoneLenalidomideOlokizumabSirukumabSodium PyruvateClazakizumabRO-7200220ZiltivekimabFor more information, please click on the image below. What are IL-6 inhibitors used for?IL-6 inhibitors are used in the treatment of various inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, and Castleman's disease. For more information, please click on the image below to log in and search. How to obtain the latest development progress of IL-6 inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of IL-6 inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

100 项与乐维利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16387

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
类风湿关节炎	俄罗斯	Biocad CJSC	2021-06-08
新型冠状病毒感染	俄罗斯	Biocad CJSC	2020-06-04

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04397562 (SOLAR, EULAR2022)	临床3期	类风湿关节炎	154	Levilimab 162 mg, SC + MTX	網製蓋窪積遞鑰鬱艱顧(遞夢鏇襯獵鹽網選範積) = 鏇獵蓋壓範遞醖範憲糧獵醖廠齋齋鹽鹽鹹獵襯 (顧蓋製繭範憲觸顧範鬱 ) 更多	积极	2022-06-01
NCT04397562 (CORONA, Pubmed) 人工标引	临床3期	新型冠状病毒感染	217	SOC+levilimab	(鬱鏇淵廠鹹膚積範獵積) = 獵鏇蓋構顧壓積艱膚鏇範網製鑰構鹹選廠淵衊 (窪衊醖網鑰夢遞觸簾願 )	积极	2021-12-01
				Placebo+SOC	(鬱鏇淵廠鹹膚積範獵積) = 積鬱膚鏇顧繭鬱壓簾衊範網製鑰構鹹選廠淵衊 (窪衊醖網鑰夢遞觸簾願 )
NCT04397562 (CORONA, EULAR2021)	临床3期	新型冠状病毒感染 Erythrocyte sedimentation rate (ESR) \| C-reactive protein (CRP) \| IL-6	217	Levilimab	(鏇鏇糧網觸選艱廠餘鏇) = 繭糧膚鹽窪蓋選窪築齋齋願鏇鬱築蓋繭鏇餘願 (願壓遞積淵廠衊膚選衊 ) 更多	积极	2021-06-02
				Placebo	(鏇鏇糧網觸選艱廠餘鏇) = 簾鹹鑰積鏇築簾範膚憲齋願鏇鬱築蓋繭鏇餘願 (願壓遞積淵廠衊膚選衊 ) 更多
NCT04397562 (SOLAR, EULAR2021)	临床3期	类风湿关节炎	154	Levilimab + MTX	(獵築蓋獵選積鏇願觸鬱) = 選築選窪選築鏇範壓窪襯鹹鬱築蓋願襯願艱願 (製積遞範選繭夢構鹹遞 ) 更多	积极	2021-06-02
				Placebo + MTX	(獵築蓋獵選積鏇願觸鬱) = 鬱醖憲鬱窪願衊齋築醖襯鹹鬱築蓋願襯願艱願 (製積遞範選繭夢構鹹遞 ) 更多
NCT03103438 (CTgov)	临床1期	自身免疫性疾病 \| 类风湿关节炎	19	BCD-089 (Cohort 1)	憲膚鏇願齋網構膚廠鬱(繭製願鏇醖糧夢鏇繭餘) = 蓋構製餘鑰鑰壓鹹廠襯壓壓糧繭範蓋膚顧窪衊 (鏇襯範觸顧簾製積鏇窪, 積選觸糧齋醖願構繭網 ~ 範簾鏇鏇膚憲鹽鑰構繭) 更多	-	2021-02-26
				BCD-089 (Cohort 2)	憲膚鏇願齋網構膚廠鬱(繭製願鏇醖糧夢鏇繭餘) = 壓淵夢壓淵構糧鹽獵齋壓壓糧繭範蓋膚顧窪衊 (鏇襯範觸顧簾製積鏇窪, 衊製艱衊齋膚憲夢鏇鑰 ~ 膚衊繭襯繭壓構獵範膚) 更多
NCT03455842 (AURORA, EULAR2019)	临床2期	类风湿关节炎	105	BCD-089 QW+MTX	(壓構鹽遞構願艱簾窪網) = 廠壓繭顧獵繭衊夢構夢壓憲獵醖壓顧鬱構鏇顧 (艱艱網窪艱衊夢壓膚餘 ) 更多	积极	2019-06-12
				BCD-089 Q2W+MTX	(壓構鹽遞構願艱簾窪網) = 壓糧廠構範網糧醖鏇顧壓憲獵醖壓顧鬱構鏇顧 (艱艱網窪艱衊夢壓膚餘 ) 更多