Clinical TrialMay 5, 2026, 08:03 AM
Viridian Elegrobart Phase 3 REVEAL-2 Met Primary Endpoint in Chronic TED
AI Summary
Viridian Therapeutics announced positive topline data from its Phase 3 REVEAL-2 clinical trial for elegrobart in patients with chronic thyroid eye disease (TED). The trial met its primary endpoint with highly statistically significant proptosis responder rates for both Q4W and Q8W dosing regimens, and also showed significant improvement in diplopia. Elegrobart was generally well tolerated, and the company plans to submit a BLA in Q1 2027, aiming to offer the first subcutaneous autoinjector for TED. This follows positive results from the REVEAL-1 trial in active TED and precedes the anticipated June 30, 2026 PDUFA date for veligrotug.
Key Highlights
- Elegrobart Phase 3 REVEAL-2 trial met its primary endpoint with highly statistically significant treatment effect (p < 0.0001).
- Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates at week 24, respectively, versus 15% placebo.
- Elegrobart Q4W achieved a statistically significant 61% diplopia responder rate at week 24, versus 38% placebo (p = 0.0118).
- Elegrobart was generally well tolerated with low rates of hearing impairment (4.1% and 8.8% placebo-adjusted rates).
- Viridian plans to submit a Biologics License Application (BLA) for elegrobart in Q1 2027.
- Veligrotug, another TED treatment, has a PDUFA target action date of June 30, 2026.