Tuesday, Viridian Therapeutics, Inc. VRDN launched topline knowledge from the THRIVE section 3 scientific trial of VRDN-001 (veligrotug), an intravenously delivered anti-insulin-like development factor-1 receptor (IGF-1R) antibody, for energetic thyroid eye illness (TED).
TED is an autoimmune situation characterised by irritation, development, and tissue injury round and behind the eyes.
THRIVE met the first and all secondary endpoints at 15 weeks after 5 infusions of veligrotug.
Veligrotug moreover confirmed a speedy onset of motion, with the bulk (53%) of veligrotug-treated sufferers reaching a proptosis response after only one infusion.
Sufferers receiving veligrotug had statistically important and clinically significant enhancements throughout the next key illness endpoints on the main efficacy evaluation timepoint of 15 weeks:
70% Proptosis (bulging eyes) responder price was noticed in sufferers receiving veligrotug, in contrast with 5% of sufferers receiving placebo (64% placebo-adjusted).
In sufferers receiving veligrotug, proptosis decreased 2.9 mm imply from baseline, in contrast with 0.5mm in sufferers receiving placebo (2.4mm placebo-adjusted).
54% full decision of diplopia (double imaginative and prescient) was noticed in sufferers receiving veligrotug, in contrast with 12% of sufferers receiving placebo (43% placebo-adjusted).
63% of sufferers receiving veligrotug achieved a diplopia response, in contrast with 20% receiving placebo (43% placebo-adjusted).
64% of sufferers receiving veligrotug achieved maximal or near-maximal therapeutic impact on scientific exercise rating (CAS), in contrast with 18% of sufferers receiving placebo (46% placebo-adjusted). CAS measures inflammatory indicators and signs of TED.
A 3.4-point imply discount in CAS from baseline was seen in sufferers receiving veligrotug, in contrast with a 1.7-point discount in sufferers receiving placebo (1.7-point placebo-adjusted).
Veligrotug was usually well-tolerated with no treatment-related severe hostile occasions (SAEs) and a 5.5% placebo-adjusted price of listening to impairment AEs.
The second section 3 trial of veligrotug, THRIVE-2, in sufferers with power TED is ongoing, and the topline knowledge readout is on monitor for year-end 2024.
Viridian anticipates submitting an FDA advertising software for veligrotug for TED in 2H 2025.
Worth Motion: On the final test on Tuesday, VRDN inventory was up 16.9% at $16.59 in the course of the premarket session.
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