PepGen Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold and cleared the Company?s Investigational New Drug Application (IND) to initiate the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in the U.S. As previously communicated, the Company opened FREEDOM-DM1 in Canada in September of this year. FREEDOM-DM1 is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study, designed to assess PGN-EDODM1 safety and tolerability, correction of mis-splicing of transcripts, and clinical functional outcome measures. Sites in both the U.S. and Canada will evaluate PGN-EDODM1 in 3 cohorts of 5 mg/kg, 10 mg/kg, and 20 mg/kg dose levels.

The decision to advance to the next dose level will be contingent upon the evaluation of safety data derived from previous dose cohorts. The Company expects to obtain proof-of-concept data, including transcript splicing and clinical outcome measures, as well as safety data, for DM1 patients in the FREEDOM-DM1 clinical study in 2024. The Company also anticipates proof-of-concept data, including exon skipping and dystrophin data, as well as safety data, at the 5 mg/kg PGN-EDO51 dose level for exon 51 amenable DMD patients in the CONNECT1-EDO51 clinical study in mid-2024.

The Company continues to expect its cash and cash equivalents to be sufficient to fund currently planned operations into 2025.