WALTHAM, Mass. – Viridian Therapeutics has announced encouraging long-term data from its Phase 3 THRIVE clinical trial evaluating veligrotug (veli), an anti-IGF-1R antibody, in patients with active thyroid eye disease (TED). According to the company, the trial demonstrated strong durability and safety results through 52 weeks, reinforcing the drug’s potential as a leading treatment for this serious autoimmune condition.
In the THRIVE trial, 70% of patients who initially responded to veligrotug treatment with a reduction in proptosis at week 15 maintained that response through week 52. Proptosis, or bulging of the eye, is a key symptom of TED. A sustained response was defined as maintaining at least a 2-millimeter reduction in proptosis from baseline without a significant worsening in the fellow eye. These results point to veligrotug’s long-term efficacy and consistency in managing the condition.
Importantly, the safety profile of veligrotug remained stable throughout the follow-up period, with most adverse events reported by week 15 having resolved by week 52.
“We view the strength of today’s durability and safety resolution data as reinforcing veli’s strong and consistently robust clinical profile,” said Steve Mahoney, President and CEO of Viridian Therapeutics. “We believe these data, along with a streamlined five-infusion regimen, position veli to become a market-leading therapeutic for TED, if approved.”
Veligrotug has already received Breakthrough Therapy Designation (BTD) from the FDA, based on its demonstrated ability to improve and resolve diplopia—a condition of double vision—particularly in chronic TED patients. The drug also showed a rapid onset of effect on proptosis in clinical testing.
In late 2024, Viridian reported that veligrotug met all primary and secondary endpoints in both THRIVE and THRIVE-2, the latter targeting patients with chronic TED. THRIVE-2 was notably the first global Phase 3 study to show statistically significant diplopia resolution in this population. Together, the two studies represent the most comprehensive clinical evaluation of a TED therapy to date.
Viridian is on track to submit a Biologics License Application (BLA) for veligrotug in the second half of 2025 and is actively preparing for a potential U.S. commercial launch in 2026.
