Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 30 |
| INN | Levilimab |
| Status | Approved |
| Drug code(s) | BCD-089 |
| Brand name | Ilsira |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Camelid-derived |
| Target(s) | IL-6R |
| Indications of clinical studies | COVID-19, rheumatoid arthritis, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2016 |
| Start of Phase 2 | February 01, 2018 |
| Start of Phase 3 | November 19, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2020 |
| Date of first US approval | |
| INN, US product name | Levilimab |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | June 9, 2020: The Ministry of Health of the Russian Federation registered the original drug Levilimab (trade name Ilsira), intended for the treatment of harsh complications of coronavirus infection - a cytokine storm.Levilimab received state approval through a fast-track mechanism, according to Decree No. 441 of the Government of the Russian Federation of April 4, 2020, since its mechanism of action is associated with the control of the cytokine storm, which is one of the manifestations of coronavirus infection. The drug can be prescribed to patients with a severe course of the disease, when the patient's immune system overreacts to the virus (the so-called cytokine storm develops) and excessive inflammation can lead to a fatal outcome. https://www.eurekalert.org/pub_releases/2020-06/b-adf060920.php NCT04397562 Phase 3 in COVID-19 started April 29, 2020. NCT04227366 Phase 3 SOLAR study started in Nov 2019. June 2019: Efficacy and adverse events data from the phase II Aurora trial in Rheumatoid arthritis presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019). NCT03455842 Phase 2 in RA started in Feb 2018. NCT03103438 first-in-humans study in healthy volunteers |
| Full address of company | 198515, Saint Petersburg, Intracity Municipality the Settlement of Strelna, ul. Svyazi, d. 38, str. 1, pomeshch. 89 Europe Russia https://biocadglobal.com/contacts |
BCD-089 is a fully human monoclonal antibody targeting membrane-bound and soluble forms of IL-6Rα, thereby blocking of IL-6 classic and trans- signalling. (https://ard.bmj.com/content/77/Suppl_2/884.2)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |