VRDN-003 Clinical Naked monospecific

Antibody Information

Entry ID	1433
INN	None
Status	Clinical
Drug code(s)	VRDN-003
Brand name	None
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	None

Therapeutic information

Target(s)	IGF-1R
Indications of clinical studies	Thyroid eye disease
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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 01, 2023
Start of Phase 2
Start of Phase 3	August 15, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Viridian Therapeutics Inc.
Licensee/Partner	None
Comments about company or candidate	Sep 2024: Viridian initiated two global phase 3 clinical trials for VRDN-003 in August as planned: REVEAL-1 and REVEAL-2 in active and chronic TED, respectively. Both trials will evaluate VRDN-003 subcutaneously administered every Q4W or Q8W and will assess outcomes versus placebo. Viridian anticipates topline data from both trials in the first half of 2026, with a BLA submission for VRDN-003 for the treatment of TED by year-end 2026. (https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-VRDN-001-Phase-3-THRIVE-Clinical-Trial-in-Patients-with-Active-Thyroid-Eye-Disease/default.aspx) June 2024: Viridian Therapeutics, Inc., a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe TED. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Details-of-Subcutaneous-VRDN-003-Phase-3-Clinical-Program-for-Patients-with-Active-and-Chronic-Moderate-to-Severe-Thyroid-Eye-Disease/default.aspx Nov 2023 Viridian report states that VRDN-003 Phase 1 trial is fully enrolled (https://investors.viridiantherapeutics.com/static-files/e3e8d85e-2799-485d-9f5b-269ea5d74e41)
Full address of company	Waltham, MA 02453 North America United States of America https://www.viridiantherapeutics.com/about/contact/

Description/comment

Shares the same binding domain as veligrotug. VRDN-003 is engineered to have an extended half-life, shown to be 40-50 days, or 4-5x that of veligrotug. VRDN-003 is a monoclonal antibody that incorporates half-life extension technology (YTE) into the sequence of VRDN-001, preserving the unique pharmacological attributes of VRDN-001 while adding the enhanced pharmacokinetics of VRDN-002. VRDN-001 and VRDN-003 are full agonists.
VRDN-003 is designed to support administration as a convenient, low volume, infrequent, subcutaneous injection for the treatment of TED. https://investors.viridiantherapeutics.com/files/doc_events/2023/12/VRDN-SC-Slides-12-18-2023-AM-final.pdf

Additional information

Anticipated events	BLA planned in 2026
Factor(s) contributing to discontinuation	None