Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 29 |
| INN | Netakimab |
| Status | Approved |
| Drug code(s) | BCD-085 |
| Brand name | Efleira |
| mAb sequence source | mAb humanized |
| 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-17A |
| Indications of clinical studies | Ankylosing Spondylitis, Psoriasis, psoriatic arthritis |
| 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) | March 15, 2015 |
| Start of Phase 2 | October 15, 2016 |
| Start of Phase 3 | December 20, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2019 |
| Date of first US approval | |
| INN, US product name | Netakimab |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | May 7, 2019: BIOCAD registered its original interleukin-17 inhibitor (anti-IL-17) in Russia for the treatment of moderate to severe plaque psoriasis. Development and clinical studies of the new drug Efleira® (international non-proprietary name: netakimab) have taken 8 years and 500 million rubles of R&D investment. Efleira® is expected to come to the market as early as in May 2019. BIOCAD's forecasts predict about a 3-fold decrease in the average costs for treatment with IL-17 inhibitors once the new drug is marketed. he efficacy and safety of Efleira® in patients with psoriasis were confirmed in Phase II and III studies: BCD-085-2 and BCD-085-7 (PLANETA). The Phase III study BCD-085-7/PLANETA was conducted in 22 certified study sites in Russia and 2 study sites in the Republic of Belarus. July 2018: Two Phase 3 studies recruiting, one not yet recruiting. NCT02380287 Phase 1 study started in March completed in Dec 2015 |
| 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 |
Described by company as innovative drug. Netakimab is a humanized monoclonal anti-IL-17 antibody that belongs to the IgG1/κ type. The light chain belongs to the VK3 structural family and contains domains CL and VL. The heavy chain consists of constant domains CH3, CH2, and CH1; the variable domain VH is substituted with a variable domain of a non-canonical antibody, VHH.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |