PepGen advances PGN-EDODM1 into 12.5 mg/kg cohort in Phase 2 FREEDOM2-DM1 trial
PEPG•Upcoming data and regulatory milestones
Results from the fully enrolled 10 mg/kg cohort are scheduled for November; 12.5 mg/kg cohort results are expected in 1H 2027.
An end-of-Phase 2 regulatory meeting is planned in 1H 2027 to discuss a registrational program; an extension update is expected by early January.
Higher-dose cohort cleared after safety review
PepGen will move PGN-EDODM1 into the highest-dose cohort in its Phase 2 FREEDOM2-DM1 study following a DSMB safety review.
The DSMB also supported raising dosing in the open-label extension, reinforcing a safety profile that has remained broadly acceptable with repeat treatment.
No serious adverse events, dose-limiting toxicities, cumulative toxicity signals, or treatment discontinuations have been reported so far in FREEDOM2 or the extension.
