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  • 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

Benzinga ·  Dec 16, 2024 21:12

-Company continues to advance PGN-EDO51 in CONNECT1-EDO51, with the 10 mg/kg cohort now fully enrolled-

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.

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.

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