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), a condition affecting the tissues around the eyes. It is currently in Phase 3 clinical trials, with studies evaluating its efficacy, safety, and tolerability in participants with both active and chronic forms of the disease.
VRDN-003 targets the insulin-like growth factor 1 receptor (IGF-1R), a receptor involved in cellular signaling. By targeting IGF-1R, VRDN-003 aims to modulate pathways implicated in Thyroid Eye Disease, potentially reducing inflammation and tissue changes associated with the condition.
VRDN-003 is being developed by Viridian Therapeutics, Inc., a biopharmaceutical company. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with Thyroid Eye Disease.
VRDN-003 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trials are designed to assess its efficacy, safety, and tolerability in participants with Thyroid Eye Disease.
VRDN-003 is being studied in several Phase 3 trials. These include NCT06625398 for chronic Thyroid Eye Disease, NCT06625411 for active Thyroid Eye Disease, and NCT06812325 for safety and tolerability. A completed trial, NCT07155668, evaluated safety, tolerability, and pharmacokinetics. All trials are randomized, double-blind, and placebo-controlled.
VRDN-003 is a distinct investigational compound developed by Viridian Therapeutics. It is not known to be the same as any other marketed drug. Its unique mechanism targets IGF-1R, and it is being evaluated specifically for Thyroid Eye Disease in clinical trials.