PGN-EDODM2 - (FREEDOM-DM1/2)

August 6, 2026: PepGen (NASDAQ: PEPG) said an independent DSMB recommended advancing the Phase 2 FREEDOM2-DM1 trial of PGN-EDODM1 in myotonic dystrophy type 1 into the third and highest multiple ascending dose cohort, 12.5 mg/kg, with no protocol changes. The DSMB also recommended raising dosing in the FREEDOM open-label extension from 5 mg/kg to 10 mg/kg after reviewing available safety data from the fully enrolled 10 mg/kg cohort and the OLE.

PGN-EDODM1 was described as generally well tolerated, with no serious adverse events, no dose-limiting toxicities, no evidence of cumulative toxicity at 5 mg/kg or 10 mg/kg, and no treatment discontinuations in FREEDOM2 or the OLE. PepGen said 7 of 8 participants in the 10 mg/kg FREEDOM2 cohort have completed dosing, and 6 of 8 participants from the 5 mg/kg FREEDOM2 cohort elected to enter the OLE, bringing total OLE enrollment to 16.

Upcoming catalysts: PepGen expects to report results from the fully enrolled 10 mg/kg FREEDOM2 cohort in November, provide an OLE update by early January, and report 12.5 mg/kg cohort results in 1H 2027, followed by an end-of-Phase 2 meeting with regulators to discuss a registrational program.