Viridian Therapeutics said its phase 3 Reveal-2 trial of elegrobart in chronic thyroid eye disease hit its primary endpoint with a strong statistical result, and both dosing schedules produced materially higher proptosis response rates than placebo.
At week 24, the every-four-weeks regimen posted a 50% proptosis responder rate, while the every-eight-weeks regimen reached 54%. Placebo was 15% in both comparisons. The p-value for each dose was below 0.0001.
The company also said the q4w arm met the EMA primary endpoint with a 47% overall responder rate versus 15% for placebo, also with p < 0.0001. Mean proptosis improvement was -1.9 mm for q4w and -2.1 mm for q8w, compared with -0.5 mm for placebo.
On diplopia, the q4w arm showed a 61% responder rate versus 38% for placebo, with p = 0.0118. The q8w arm posted 55% versus 38% for placebo, with p = 0.0419. Complete diplopia resolution was 44% for q4w, 36% for q8w, and 25% for placebo.
Reveal-2 enrolled 204 patients: 70 on q4w, 68 on q8w, and 66 on placebo.
On safety, Viridian said 91% of elegrobart-treated patients completed the full course. There were no treatment-related serious adverse events. Reported hearing impairment rates were low, at 4.1% for q4w and 8.8% for q8w placebo-adjusted rates.
Viridian said Reveal-2 is the second positive phase 3 trial for elegrobart, following Reveal-1 in active TED. The company remains on track to file a biologics license application in the first quarter of 2027.
Viridian also said veligrotug remains on track for a June 30, 2026 PDUFA date. The market has reacted to these announcements by moving the company's shares 30.26% to a price of $18.315. Check out the company's full 8-K submission here.
