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-
-公司继续在CONNECT1-EDO51中推进PGN-EDO51，目前10 mg/kg的剂量组已完全招募完毕-
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.（纳斯达克：PEPG）是一家临床阶段生物技术公司，致力于推进下一代寡核苷酸疗法，目标是改变严重神经肌肉和神经疾病的治疗。公司今日宣布，已收到美国食品和药物管理局（FDA）发出的临床持有通知，涉及其申请在杜氏肌营养不良症（DMD）患者中启动CONNECT2-EDO51临床试验的临床新药（IND）申请。FDA表示将在30天内向公司提供正式的临床持有信函。
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针对DMD患者进行的PGN-EDO51的第二期多国、双盲、安慰剂对照、多次递增剂量、25周的临床试验。该研究在英国进行。
