Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL?2 Clinical Trial in Chronic Thyroid Eye Disease
Viridian Therapeutics announced positive topline results from the REVEAL-2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease. The trial met its primary endpoint with high statistical significance (p < 0.0001) and showed significant improvement in proptosis and diplopia responder rates.
Viridian Therapeutics, Inc. announced positive topline data from the REVEAL-2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease (TED). The trial evaluated two dosing regimens, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo, and enrolled 204 patients. REVEAL-2 met its primary endpoint for both the FDA and EMA with high statistical significance. Elegrobart was generally well tolerated with a safety profile consisting of adverse events expected from the anti-IGF-1R class. The Q4W and Q8W treatment arms showed significant improvement in proptosis responder rates (54% and 52% vs 15% placebo) and diplopia responder rates (61% and 55% vs 38% placebo).
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