Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VRDN-001
Veligrotug · 4 trials · 1 indication
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were not imputed.
Proptosis responder in the study eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the study eye (without a corresponding increase of ≥2 mm in the fellow eye) as measured by exophthalmometer. Missing data were imputed with the Multiple Imputation method.
| Arm | Type | Description |
|---|---|---|
| Veligrotug 10 mg/kg | EXPERIMENTAL | Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks. |
| Veligrotug 3 mg/kg | EXPERIMENTAL | Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks. |
| Veligrotug/Veligrotug | EXPERIMENTAL | Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 milligrams (mg)/kilogram (kg) every 3 weeks (Q3W) for 12 weeks. |
| Placebo/Veligrotug | EXPERIMENTAL | Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 mg/kg Q3W for 12 weeks. |
| Veligrotug | EXPERIMENTAL | Participants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks. |
| Placebo | EXPERIMENTAL | Participants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Veligrotug | DRUG | 5 infusions of veligrotug |
| Placebo | DRUG | 5 IV Infusions of veligrotug matched placebo |
Inclusion Criteria: * Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment * Must agree to use highly effective contraception method as specified in the protocol * Female TED p...
Veligrotug is an investigational therapy being developed for the treatment of thyroid eye disease (TED), an autoimmune condition affecting the tissues around the eyes. It is not yet approved for any indication and remains in clinical development. The clinical program has enrolled adults 18 years and older with TED across multiple countries.
Veligrotug targets the insulin-like growth factor 1 receptor, or IGF1R. It acts as an antagonist, meaning it blocks signaling through this receptor. IGF1R is implicated in the inflammation and tissue expansion that occur in thyroid eye disease, and antagonizing it is the intended mechanism of action for Veligrotug in this condition.
Veligrotug is being developed by Viridian Therapeutics, Inc., which trades under the ticker VRDN. The company is the sponsor of the clinical program evaluating the drug in thyroid eye disease. Viridian Therapeutics has advanced Veligrotug into Phase 3 development for this indication.
Veligrotug is in Phase 3 clinical development for thyroid eye disease. It is an investigational drug and has not been approved by the FDA for any use. The Phase 3 program includes four completed trials with a total enrollment of 671 participants, all randomized, double-blind, and placebo-controlled.
Veligrotug has been evaluated in four completed Phase 3 trials in thyroid eye disease: NCT06384547, NCT06179875, NCT06021054, and NCT05176639. These studies enrolled a combined 671 participants across sites in the United States, Europe, Australia, and Turkey, and all trials have completed their planned enrollment and follow-up.
Veligrotug has received Breakthrough Therapy and Priority Review designations from the FDA for thyroid eye disease. These designations are intended to expedite the development and review of drugs that may offer significant improvements over existing therapies. Veligrotug remains investigational and is not approved for commercial use.