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Tuesday, Viridian Therapeutics, Inc. (NASDAQ:VRDN) released topline data from the THRIVE phase 3 clinical trial of VRDN-001 (veligrotug), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, for active thyroid eye disease (TED).
TED is an autoimmune condition characterized by inflammation, growth, and tissue damage around and behind the eyes.
THRIVE met the primary and all secondary endpoints at 15 weeks after five infusions of veligrotug.
Veligrotug additionally showed a rapid onset of action, with the majority (53%) of veligrotug-treated patients achieving a proptosis response after just one infusion.
Patients receiving veligrotug had statistically significant and clinically meaningful improvements across the following key disease endpoints at the primary efficacy analysis timepoint of 15 weeks:
70% Proptosis (bulging eyes) responder rate was observed in patients receiving veligrotug, compared with 5% of patients receiving placebo (64% placebo-adjusted).
In patients receiving veligrotug, proptosis decreased 2.9 mm mean from baseline, compared with 0.5mm in patients receiving placebo (2.4mm placebo-adjusted).
54% complete resolution of diplopia (double vision) was observed in patients receiving veligrotug, compared with 12% of patients receiving placebo (43% placebo-adjusted).
63% of patients receiving veligrotug achieved a diplopia response, compared with 20% receiving placebo (43% placebo-adjusted).
64% of patients receiving veligrotug achieved maximal or near-maximal therapeutic effect on clinical activity score (CAS), compared with 18% of patients receiving placebo (46% placebo-adjusted). CAS measures inflammatory signs and symptoms of TED.
A 3.4-point mean reduction in CAS from baseline was seen in patients receiving veligrotug, compared with a 1.7-point reduction in patients receiving placebo (1.7-point placebo-adjusted).
Veligrotug was generally well-tolerated with no treatment-related serious adverse events (SAEs) and a 5.5% placebo-adjusted rate of hearing impairment AEs.
The second phase 3 trial of veligrotug, THRIVE-2, in patients with chronic TED is ongoing, and the topline data readout is on track for year-end 2024.
Viridian anticipates submitting an FDA marketing application for veligrotug for TED in 2H 2025.
Price Action: At the last check on Tuesday, VRDN stock was up 16.9% at $16.59 during the premarket session.
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