Viridian Therapeutics’ veligrotug has shown one-year durability in a Phase III trial in patients with active thyroid eye disease (TED).
The company said that 70% of patients treated with veligrotug, an intravenous anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, who were proptosis responders at week 15, maintained their proptosis response up to week 52 in the pivotal THRIVE trial (NCT05176639).
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Maintenance of response is defined as responders at week 15 who still had at least a 2mm reduction in proptosis compared to baseline at week 52, without worsening in the other eye.
TED is an autoimmune condition characterised by inflammation, growth, and damage to tissues around and behind the eye.
There were no changes to the safety profile in the follow-up period. The vast majority of adverse events (AEs) reported at the week 15 primary analysis had resolved by week 52.
Based on the data, the company will submit a biologics licence application (BLA) submission to the US Food and Drug Administration (FDA) in the second half of 2025, with hopes for a 2026 launch.
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By GlobalDataViridian’s president and CEO Steve Mahoney said: “We view the strength of [the] durability and safety resolution data as reinforcing veligrotug’s strong and consistently robust clinical profile. We believe that the totality of veligrotug’s clinical data continues to demonstrate its potential to be the treatment of choice for patients living with TED. We believe these data, together with a streamlined dosing regimen of five infusions, position veligrotug to become a market-leading TED therapeutic if approved.”
Topline veligrotug data achieved all endpoints
The THRIVE trial in active TED evaluated five infusions of veligrotug or placebo every three weeks, with primary topline analysis at week 15 and then followed patients through week 52.
Primary analysis, published in 2024, found that veligrotug met all of its primary and secondary endpoints and was generally well-tolerated in both the THRIVE and THRIVE-2 (NCT06021054) trials for active and chronic TED, respectively. The THRIVE-2 trial was a Phase III clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution. Further data from THRIVE-2 is expected later this year.
Amgen’s Tepezza (teprotumumab) is an IGF-1R already approved in TED. The drug gained FDA approval in 2020. Amgen acquired the drug last year through a $26bn takeover of Horizon.
GlobalData reports that Tepezza hit blockbuster status in 2021, reaching sales of $1.66bn; however, sales dropped in 2023 after the FDA added a new warning to the Tepezza label in July 2023, highlighting potential hearing impairment, including hearing loss, as a potential side effect. In 2030, sales of Tepezza are expected to reach $2.84bn, according to GlobalData analysis.
Meanwhile, GlobalData predicts that veligrotug sales will reach $831m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
