原始出處紀錄
決策級主要結果 (Topline)
Opus Genetics:OPGx-BEST1 第1/2期第1隊列3個月頂線數據
Low-dose Cohort 1 data show 75% of evaluable patients met the FDA-aligned microperimetry endpoint and 80% had structural improvement. Cohort 2 is over-enrolled; 6-month Cohort 1 and 3-month Cohort 2 data are now expected in Q2 2027, with pivotal trial dosing slated to begin in 2027.
關鍵事實
- 申報時間
- 2026年9月11日 上午11:48
- 事件
- 主要結果 (Topline)
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- 第一組劑量
- 1.5 × 10^9 vg/眼
- 第二組劑量
- 4.5 × 10^9 vg/眼
- 最佳矯正視力改善
- 5 名受試者中有 3 名
- 第二組初步數據
- 2027 年第二季
- 第二組收案
- 8 名受試者
- 結構改善
- 5 名受試者中有 4 名
- 第二組給藥完成
- 2026 年第四季
- 微周邊視野改善
- 4 名受試者中有 3 名
來源摘錄
EX-99.1 2 ef20081922_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 OPGx-BEST1 Gene Therapy Phase 1/2 Study Low Dose Cohort 1 3-month Results September 9, 2026 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate，” “expect，” “intend，” “aim，” “may，” “ongoing，” “plan，” “potential，” “predict，” “project，” “should，” “will，” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Such statements include, but are not limited to, statements related to our continued clinical development, clinical results, preclini