1차 출처 기록
결정급탑라인 결과
Viridian: REVEAL-1 3상 탑라인, 활동성 TED에서 elegrobart 양성 결과
REVEAL-1은 24주차 안구돌출 반응률에서 주요 평가변수를 높은 통계적 유의성으로 달성했으며, Q4W 및 Q8W 투여군 모두에서 확인되었습니다. 또한 임상적으로 의미 있는 복시 해소와 전반적으로 양호한 내약성 프로파일을 보였으며, 2027년 1분기 BLA 제출 가능성을 제시합니다.
핵심 사실
출처 발췌
EX-99.1 2 d27955dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL-1 Clinical Trial in Active Thyroid Eye Disease - REVEAL-1 met the primary endpoint of Q4W proptosis responder rate (PRR) with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% PRR versus 18% placebo at week 24 - - Complete resolution of diplopia in 51% of patients treated Q4W versus 16% placebo at week 24 - - Elegrobart was generally well tolerated in both dose groups with low rates of hearing impairment - - REVEAL-2, a phase 3 clinical trial evaluating elegrobart in patients with chronic TED, is on track for topline readout in Q2 2026; BLA submission anticipated in Q1 2