Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 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 development and has not yet been approved by regulatory authorities. The drug is being studied in patients aged 18 years and older.
Veligrotug is being developed by Viridian Therapeutics, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol VRDN. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with Thyroid Eye Disease.
Veligrotug is currently in Phase 3 clinical development for Thyroid Eye Disease. It has received Breakthrough Therapy designation and Priority Review designation from the FDA, indicating the agency's recognition of its potential to address a serious condition. However, it remains investigational and is not yet approved for commercial use.
Veligrotug has been studied in four completed Phase 3 clinical trials. These include NCT05176639, NCT06021054, NCT06179875, and NCT06384547, all conducted in patients with Thyroid Eye Disease. The trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 671 participants across multiple countries.
Yes, Veligrotug is also known as VRDN-001. Clinical trial records refer to the drug by both names, with studies such as NCT05176639 and NCT06021054 using the VRDN-001 designation. This naming convention is common during drug development before a brand name is established.
Veligrotug is a small molecule designed to target the underlying mechanisms of Thyroid Eye Disease. While the specific molecular target is not disclosed in the available information, the drug is being developed to address the inflammatory and tissue changes associated with the condition, potentially offering a new treatment option for patients.