Viridian Therapeutics announced positive topline data from the THRIVE-2 Phase 3 clinical trial of veligrotug (veli), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with chronic thyroid eye disease (TED). TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eyes. The Phase 3 trial, detailed in a company press release, shows:

• Veligrotug met all primary and secondary endpoints with high statistical significance in THRIVE-2, achieving a week 15 proptosis responder rate (PRR) of 56% (placebo-adjusted PRR of 48%, p < 0.0001)  
• THRIVE-2 is the first global Phase 3 study in patients with chronic TED to demonstrate a statistically significant and clinically meaningful 56% diplopia responder rate (placebo-adjusted rate of 31%, p = 0.0006) and 32% rate of diplopia complete resolution (placebo-adjusted rate of 18%, p = 0.0152)
• Veligrotug was generally well-tolerated with 94% of patients completing their treatment course and a 9.6% placebo-adjusted rate of hearing impairment  
• BLA submission for veligrotug on track for second half of 2025; potential to transform the standard of care in TED with differentiated clinical profile demonstrated in the broadest population studied in a global Phase 3 study across active and chronic TED patients to date  
• REVEAL-1 and REVEAL-2, global Phase 3 clinical trials of subcutaneous VRDN-003 evaluating every 4-week (Q4W) or every 8-week (Q8W) regimens, are both currently dosing and on track for topline data in 1H 2026; VRDN-003 is a half-life-extended anti-IGF-1R antibody with the same binding domain as veligrotug.  

“I’ve been treating TED for over 30 years, and these results in the broadest population of TED patients are highly encouraging,” said Steven Leibowitz, MD, Associate Clinical Professor of Ophthalmology, Stein Eye Institute, University of California Los Angeles and THRIVE-2 investigator. “Resolving double vision or even improving it in chronic TED patients can really change their lives. I see veligrotug’s potential product profile as highly compelling with a rapid onset of treatment effect, diplopia benefit across a broad TED population, shorter dosing regimen, and favorable safety profile.”

According to Viridian’s press release, the company’s strong cash position of $753 million (as of Sept. 30, 2024) provides cash runway into the second half of 2027 through the anticipated commercial launch of veligrotug, topline results and BLA submission for subcutaneous VRDN-003, and multiple FcRn inhibitor clinical catalysts.