Netakimab Approved Naked monospecific

Antibody Information

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

Therapeutic information

Target(s)	IL-17A
Indications of clinical studies	Ankylosing Spondylitis, Psoriasis, psoriatic arthritis
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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

Description/comment

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.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None