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-
-公司繼續在CONNECT1-EDO51中推進PGN-EDO51，目前10 mg/kg的劑量組已完全招募完畢-
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：PEPG）是一家臨床階段生物技術公司，致力於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疾病的治療。公司今日宣佈，已收到美國食品和藥物管理局（FDA）發出的臨床持有通知，涉及其申請在杜氏肌營養不良症（DMD）患者中啓動CONNECT2-EDO51臨床試驗的臨床新藥（IND）申請。FDA表示將在30天內向公司提供正式的臨床持有信函。
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針對DMD患者進行的PGN-EDO51的第二期多國、雙盲、安慰劑對照、多次遞增劑量、25周的臨床試驗。該研究在英國進行。
譯文內容由第三人軟體翻譯。
