Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | IGF-1R |
| Indications of clinical studies | Thyroid eye disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| 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 | 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/ |
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
| Anticipated events | BLA planned in 2026 |
| Factor(s) contributing to discontinuation | None |