Purpose

Veligrotug, an investigational full antagonist monoclonal antibody to IGF-1R, led to significant proptosis improvement at the population level in the THRIVE phase 3 trial in active TED (NCT05176639). This analysis further characterizes the magnitude of proptosis response at the individual-patient level, enhancing understanding of veligrotug’s treatment effect.

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Methods

Adults with moderate-to-severe active TED (onset ≤15 months, proptosis ≥3 mm above normal, clinical activity score ≥3) received 10 mg/kg veligrotug or placebo, each administered once every 3 weeks for a total of 5 IV infusions. Proptosis was assessed by Hertel exophthalmometry through Week 15; responders had a ≥2-mm reduction from baseline without a ≥2-mm increase in the fellow eye.

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Results

Overall, proptosis significantly improved for veligrotug vs placebo at Week 15 (mean reduction: 2.9 mm vs 0.5 mm, p<0.0001; secondary endpoint). Of 107 patients (veligrotug, n=69; placebo, n=38) with both baseline and Week 15 Hertel measurements, 71% vs 5% were proptosis responders for veligrotug vs placebo at Week 15. Proptosis reduction of ≥3 mm was achieved in 55% vs 3% and ≥4 mm in 23% vs 0% for veligrotug vs placebo patients; proptosis increased in 21% of placebo but in none of the veligrotug patients. Among veligrotug proptosis responders, mean proptosis reduction was 2.4 mm at Week 3 and 3.7 mm at Week 15. Individual patient data for veligrotug and placebo arms will be shown in the presentation. Overall, veligrotug was generally well tolerated; the majority of AEs were mild, with no treatment-related serious AEs, and a low treatment discontinuation rate (4%).

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Conclusion

A 12-week 5-infusion treatment regimen of 10 mg/kg veligrotug was generally well tolerated and demonstrated rapid and significant improvement in proptosis in active TED. Veligrotug-treated patients had no increase in proptosis, and among the 71% who were responders, the magnitude of reduction was over 3 mm for most patients, within the range achieved by surgical decompression. Assessing proptosis response at the individual‑patient level may better inform treatment expectations.

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Additional Authors

First name	Last name	Base Hospital / Institution
Antonio Manuel	Garrido-Hermosilla	Hospital Universitario Virgen Macarena, Universidad de Sevilla
Peerooz	Saeed	Amsterdam UMC location AMC
Javier	Vicente Andreu	Metavisión Arruzafa, Hospital La Arruzafa
Eckart	Bertelmann	Charité University Medicine Berlin, Dept. of Ophthalmology
Vickie	Lee	Imperial College Healthcare NHS Trust – Western Eye Hospital
Edwina	Eade	University of Sydney
Marta	Pérez-López	Hospital Universitario y Politécnico La Fe
Marco	Sales-Sanz	Hospital Universitario Ramón y Cajal
Patrice	Rodien	Centre Hospitalier Universitaire d’Angers, Dept. of Endocrinology
Ashley	Pajak	Viridian Therapeutics, Inc.
Abhijit	Narvekar	Viridian Therapeutics, Inc.

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