OR31-04 Efficacy and Safety of Veligrotug (VRDN-001), a Full Antagonist Monoclonal Antibody to IGF-1 Receptor, in Active Thyroid Eye Disease (TED): THRIVE Phase 3 Topline Results
Bibliographic record
Abstract
Abstract Disclosure: R. Mudumbai: Viridian Therapeutics, Inc., Nicox Ophthalmics, Stoke Pharmaceuticals. S. Leibowitz: Viridian Therapeutics, Inc., Lassen Therapeutics LLC, Amgen. Y. Michael T.: Viridian Therapeutics, Inc., Ipsen Innovations, Sling Therapeutics. K. Cockerham: Viridian Therapeutics, Inc., Horizon Therapeutics, Immunovant, Lassen Therapeutics LLC, Tourmaline, Roche. J. Abrams: Viridian Therapeutics, Inc., Horizon Therapeutics. R.E. Turbin: Viridian Therapeutics, Inc., Horizon Therapeutics, Medtronic. N. Nijhawan: Viridian Therapeutics, Inc. S. Zhang-Nunes: Viridian Therapeutics, Inc., Amgen, Tarsus. A. Kossler: Viridian Therapeutics, Inc., Horizon Therapeutics, Sling Therapeutics, Lassen Therapeutics LLC, Immunovant, Genetech, Argenx, Acelyrin. C. Michalsky: Viridian Therapeutics, Inc. A. Narvekar: Viridian Therapeutics, Inc. T. Ciulla: Viridian Therapeutics, Inc.. Introduction: Veligrotug, a full antagonist humanized monoclonal antibody to the IGF-1 receptor (IGF-1R), is an investigational treatment for thyroid eye disease (TED). Clinical and preclinical evidence indicate a central role for IGF-1R antagonism in reducing the inflammation and proptosis that occur in TED. We assessed topline efficacy and safety results at 15 weeks from an ongoing phase 3 randomized double-masked placebo-controlled trial of veligrotug vs placebo in patients with active TED (THRIVE, NCT05176639). Methods: Adults with moderate-to-severe active TED (onset ≤15 months, proptosis ≥3 mm, and clinical activity score [CAS] ≥3) were randomized to 5 IV infusions 3 weeks apart of either 10 mg/kg veligrotug or placebo. The primary endpoint in North America (proptosis responder rate [PRR], defined as ≥2-mm reduction vs baseline by Hertel exophthalmometry), PRR by MRI/CT, complete resolution of diplopia, mean changes from baseline in proptosis and CAS, and treatment-emergent adverse events (AEs) were assessed through 15 weeks, with follow-up ongoing through 52 weeks. Results: A total of 113 patients were randomized to veligrotug (n=75) or placebo (n=38) and included in the intention-to-treat population. At baseline, mean proptosis was 23.2 mm in each group; CAS was 4.5 vs 4.8 and diplopia was present in 67% vs 68% of patients for veligrotug vs placebo. At 15 weeks, PRR by Hertel was 70% vs 5% (p<0.0001) for veligrotug vs placebo, with a mean reduction of 2.9 mm vs 0.5 mm (p<0.0001). PRR by MRI/CT was 69% vs 9% (p<0.0001) for veligrotug vs placebo, with a mean reduction of 2.9 mm vs 0.6 mm (p<0.0001). Mean CAS decreased by 3.4 vs 1.7 (p<0.0001) for veligrotug vs placebo. In patients with diplopia, complete resolution of diplopia occurred in 54% (27/50) vs 12% (3/26) (p<0.0001) for veligrotug vs placebo. AEs occurred for 66 (88%) veligrotug vs 24 (63%) placebo patients, and most were mild; 4 patients (veligrotug) had serious AEs (all unrelated to treatment). Hearing impairment AEs were reported for 12 (16%) veligrotug vs 4 (11%) placebo patients. Conclusions: Topline results from the THRIVE phase 3 trial show 5 IV infusions of 10 mg/kg veligrotug were well tolerated and led to significant and clinically meaningful improvements in proptosis, CAS, and diplopia at 15 weeks. Additional follow-up through 52 weeks is ongoing. Presentation: Monday, July 14, 2025
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".