FDA lifts clinical hold on PepGen's DM1 program; US Phase 1 trial to begin

PepGen Inc.

FDA cleared IND for FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in DM1 patients in the US.
Target dose levels in the study: 5 mg/kg, 10 mg/kg, and 20 mg/kg.
Proof-of-concept data (safety, transcript splicing, clinical outcomes) at 5 mg/kg expected in 2024.
CONNECT1-EDO51 DMD study proof-of-concept data (exon skipping, dystrophin) at 5 mg/kg expected mid-2024.
Cash and equivalents expected to fund operations into 2025.

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