Viridian Therapeutics on Tuesday reported topline Phase 3 data for its rare autoimmune disease drug veligrotug as it aims to compete with Amgen and Horizon’s Tepezza.
Veligrotug hit on all primary and secondary endpoints in a 113-patient trial measuring its efficacy in thyroid eye disease, or TED, Viridian said Tuesday morning. After 15 weeks, the trial saw a 70% proptosis responder rate (PRR) in the active arm, compared to 5% in the placebo group (p<0.0001). The placebo-adjusted PRR came in at 64%.
The data ensure the program is on track for an FDA submission in the second half of 2025. Viridian is also conducting another Phase 3 trial in chronic TED, with both studies expected to make up the backbone of its FDA pitch.
Viridian’s stock $VRDN was up 11% in premarket trading on Tuesday.
In a note last week, Leerink analyst Thomas Smith outlined expectations for how Viridian’s drug might measure up to Tepezza. Results for Veligrotug (previously known as VRDN-001) appeared to fall in Smith’s “base case” scenario, being “generally competitive and consistent” with Tepezza data.
But Smith also noted that the Tepezza Phase 3 study, measured out to 24 weeks instead of 15, saw an 83% absolute PRR and 73% placebo-adjusted PRR.