Viridian Therapeutics announced positive topline data from the THRIVE Phase 3 clinical trial of VRDN-001, now known as veligrotug, an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED). 

According to the company, veligrotug achieved all primary and secondary endpoints in THRIVE, which the company says is the largest Phase 3 trial conducted to date of an anti-IGF-1R antibody in TED, with a week 15 proptosis responder rate (PRR) of 70% and a placebo-adjusted PRR of 64% (p < 0.0001). 

All secondary endpoints were highly statistically significant (p < 0.0001), with clinically meaningful patient outcomes, including complete resolution of diplopia in 54% of patients (placebo-adjusted rate of 43%) and reduction of Clinical Activity Score to 0 or 1 in 64% of patients (placebo-adjusted reduction of 46%) treated with veligrotug. 

In addition, the company says veligrotug was generally well-tolerated with no treatment-related serious adverse events and a 5.5% placebo-adjusted rate of hearing impairment adverse events. 

According to the company, the THRIVE-2 study of veligrotug in patients with chronic TED is fully enrolled with topline data readout on track for year-end 2024; and BLA submission is anticipated in the second half of 2025.

In other company news, Viridian announced that the REVEAL-1 and REVEAL-2, global Phase 3 trials of VRDN-003 dosed every 4 or 8 weeks, was initiated in August. VRDN-003 is a subcutaneous, half-life-extended anti-IGF-1R antibody with the same binding domain as veligrotug. 

For more, click here.