PepGen Announces Clinical Hold In The U.S. On IND Application To Initiate CONNECT2-EDO51 Phase 2 Study Of PGN-EDO51 For Duchenne Muscular Dystrophy; Continues To Advance PGN-EDO51 In CONNECT1-EDO51, With The 10 Mg/kg Cohort Now Fully Enrolled
PepGen Announces Clinical Hold In The U.S. On IND Application To Initiate CONNECT2-EDO51 Phase 2 Study Of PGN-EDO51 For Duchenne Muscular Dystrophy; Continues To Advance PGN-EDO51 In CONNECT1-EDO51, With The 10 Mg/kg Cohort Now Fully Enrolled
-Company continues to advance PGN-EDO51 in CONNECT1-EDO51, with the 10 mg/kg cohort now fully enrolled-
-公司繼續推進 CONNECT1-EDO51 中的 PGN-EDO51，10 mg/kg 隊列現已全部入組-
PepGen Inc. (NASDAQ:PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application to initiate the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy (DMD). The FDA indicated they will provide an official clinical hold letter to the Company within 30 days.
PepGen Inc.（納斯達克股票代碼：PEPG）是一家處於臨床階段的生物技術公司，正在推進下一代寡核苷酸療法，目標是改變嚴重神經肌肉和神經系統疾病的治療方法。該公司今天宣佈，該公司收到了美國食品藥品監督管理局（FDA）關於其啓動針對杜興肌肉萎縮症患者的 CONNECT2-EDO51 臨床試驗的臨床暫停通知 phy (DMD)。美國食品藥品管理局表示，他們將在30天內向公司提供一份正式的臨床保留信。
CONNECT2 is PepGen's Phase 2 multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial of PGN-EDO51 in patients with DMD. The study is open in the United Kingdom.
CONNECT2 是 PepGen 針對 DMD 患者進行的 PGN-EDO51 的 2 期跨國、雙盲安慰劑對照、多次遞增劑量、爲期 25 周的臨床試驗。該研究在英國開放。
