Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VRDN-003 · 4 trials · 2 indications
Description: Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer \[without a corresponding increase of ≥2 mm in the other eye\]
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the most proptotic eye as measured by exophtalmometer \[without a corresponding increase of ≥2 mm in the other eye\]
| Arm | Type | Description |
|---|---|---|
| VRDN-003 every 4 weeks using autoinjector | EXPERIMENTAL | 6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\] |
| VRDN-003 every 8 weeks using autoinjector | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] |
| VRDN-003 every 8 weeks using vial and syringe | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] |
| VRDN-003 every 4 weeks | EXPERIMENTAL | 6 subcutaneous administrations of VRDN-003 |
| VRDN-003 every 8 weeks | EXPERIMENTAL | 3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo |
| Placebo every 4 weeks | PLACEBO_COMPARATOR | 6 subcutaneous administrations of placebo |
| Name | Type | Description |
|---|---|---|
| VRDN-003 | DRUG | VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). |
| Autoinjector | DEVICE | The autoinjector is a single-dose, disposable, ready-to-use delivery device |
| Placebo | DRUG | Placebo injections that appear identical to VRDN-003 injections but have no active drug. |
Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003 * Not require immediate ophthalmological or orbital surgery in the study eye for any reason * Must agree to use highly effective cont...
VRDN-003 is an investigational small molecule being developed for the treatment of thyroid eye disease (TED), an endocrine condition. It is being studied in both active and chronic forms of TED. VRDN-003 has not been approved by the FDA and remains in clinical development.
VRDN-003 targets the IGF-1R receptor, also known as the insulin-like growth factor 1 receptor. IGF-1R is a cell surface receptor involved in signaling pathways relevant to thyroid eye disease. By targeting IGF-1R, VRDN-003 is designed to interfere with the receptor activity thought to contribute to TED.
VRDN-003 is being developed by Viridian Therapeutics, Inc., which trades on the Nasdaq under the ticker VRDN. Viridian is a biopharmaceutical company focused on developing therapies for serious and rare diseases, and VRDN-003 is one of its clinical-stage assets in thyroid eye disease.
VRDN-003 is in Phase 3 clinical development for thyroid eye disease. Four Phase 3 trials have been registered, three of which are active and one completed. VRDN-003 is investigational and has not received FDA approval.
VRDN-003 has been studied in four Phase 3 trials in thyroid eye disease. These include NCT07155668, a completed safety, tolerability, and pharmacokinetics study; NCT06812325, a safety and tolerability study; NCT06625411, a study in active TED; and NCT06625398, a study in chronic TED. Total enrollment across these trials is 743 participants.
Yes, the VRDN-003 Phase 3 trials are randomized, double-blind, and placebo-controlled. They enrolled adults aged 18 years and older with thyroid eye disease across sites in the United States and several European countries, including Germany, Spain, Poland, Hungary, the Netherlands, France, the United Kingdom, and Turkey.