Delving into the Latest Updates on Levilimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Ilsira

Target

IL-6RA

Mechanism

IL-6RA antagonists(Interleukin-6 receptor alpha subunit antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesRespiratory Diseases+ [1]

Active Indication

Rheumatoid ArthritisCOVID-19

Inactive Indication-

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad CJSC

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

RU (04 Jun 2020),

COVID-19

Regulation-

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Structure/Sequence

Sequence Code 432066943L

Source: *****

Sequence Code 432066942H

Source: *****

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.

Start Date07 Dec 2022

Sponsor / Collaborator

Biocad CJSC

NCT04397562

/ CompletedPhase 3

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.

Start Date29 Apr 2020

Sponsor / Collaborator

Biocad CJSC

NCT04227366

/ CompletedPhase 3

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.

Start Date19 Nov 2019

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with Levilimab

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100 Translational Medicine associated with Levilimab

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100 Patents (Medical) associated with Levilimab

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10

Literatures (Medical) associated with Levilimab

01 Jan 2023·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

Author: Edwards, Christopher John ; van der Heijde, Désirée ; de Souza, Savia ; Stamm, Tanja A ; Caporali, Roberto ; Sepriano, Alexandre ; Schoones, Jan W ; Verschueren, Patrick ; 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.

01 Dec 2021·Inflammation ResearchQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: Gordeev, Ivan G ; Mazurov, Vadim I ; Pasechnik, Elena S ; Dokukina, Ekaterina A ; Eremeeva, Anna V ; 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 ; Popov, Vladimir V ; Protsenko, Denis N ; Zinkina-Orikhan, Arina V ; Moiseeva, Olga M ; 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).

01 Jan 2021·mAbsQ2 · MEDICINE

Antibodies to watch in 2021

Q2 · MEDICINE

Review

Author: 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.

100 Deals associated with Levilimab

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	RU	Biocad CJSC	08 Jun 2021
COVID-19	RU	Biocad CJSC	04 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04397562 (SOLAR, EULAR2022)	Phase 3	Rheumatoid Arthritis	154	Levilimab 162 mg, SC + MTX	xrwwnmhwzt(qsqhpoorox) = xerfelhagk jseqhxrfgi (houmjejfva ) View more	Positive	01 Jun 2022
NCT04397562 (CORONA, Pubmed) Manual	Phase 3	COVID-19	217	SOC+levilimab	(ggkmwvlfkk) = sjnwyqpdgz kdcypgpdur (uxioiwikwq )	Positive	01 Dec 2021
				Placebo+SOC	(ggkmwvlfkk) = xwtlqjpkpa kdcypgpdur (uxioiwikwq )
NCT04397562 (CORONA, EULAR2021)	Phase 3	COVID-19 Erythrocyte sedimentation rate (ESR) \| C-reactive protein (CRP) \| IL-6	217	Levilimab	(yhliotvdwq) = uwyncghunu xkiulduteg (jhqvryvlno ) View more	Positive	02 Jun 2021
				Placebo	(yhliotvdwq) = jxufqlksfd xkiulduteg (jhqvryvlno ) View more
NCT04397562 (SOLAR, EULAR2021)	Phase 3	Rheumatoid Arthritis	154	Levilimab + MTX	(cpugkgjdse) = ugztmddjyp lzyabiuvzx (hjfzuwwyil ) View more	Positive	02 Jun 2021
				Placebo + MTX	(cpugkgjdse) = jccnspmgis lzyabiuvzx (hjfzuwwyil ) View more
NCT03103438 (CTgov)	Phase 1	Autoimmune Diseases \| Rheumatoid Arthritis	19	BCD-089 (Cohort 1)	optmqhdhnq(omoblqngig) = hxpgaswjix mraexrlspo (inioxjtjdx, yhklgckrjh - vybaqbikzy) View more	-	26 Feb 2021
				BCD-089 (Cohort 2)	optmqhdhnq(omoblqngig) = uwfdnfxdxw mraexrlspo (inioxjtjdx, fmzujeytge - osxmadxpan) View more
NCT03455842 (AURORA, EULAR2019)	Phase 2	Rheumatoid Arthritis	105	BCD-089 QW+MTX	(kgbvhgjrjb) = jzdjboysik ildckrxbgl (hkyfdlpznq ) View more	Positive	12 Jun 2019
				BCD-089 Q2W+MTX	(kgbvhgjrjb) = mvprodfsbv ildckrxbgl (hkyfdlpznq ) View more