PepGen receives Health Canada clearance to begin Phase 1 study of PGN-EDODM1 in DM1; FDA grants Orphan Drug Designation

PepGen Inc.

Health Canada issued No Objection Letter for CTA to start FREEDOM-DM1 Phase 1 trial of PGN-EDODM1 in myotonic dystrophy type 1.
FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
Phase 1 study is a randomized, placebo-controlled, SAD study enrolling ~24 adults; dose escalation from 5 mg/kg to 10 mg/kg then 20 mg/kg.
Initial results from the FREEDOM-DM1 study are expected in 2024.
FDA clinical hold on US IND for PGN-EDODM1 remains; company continues working to resolve it.

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