PepGen Inc. announced its voluntary decision to temporarily pause the Phase 2 CONNECT2-EDO51 study of PGN-EDO51 in patients with Duchenne muscular dystrophy (DMD). This pause will remain in effect until the company can review results from the 10 mg/kg cohort in the ongoing Phase 2 CONNECT1-EDO51 study.
The company stated that this strategic pause allows for the collection of additional safety data and a thorough assessment of the impact of the 10 mg/kg dose of PGN-EDO51 on dystrophin levels. This review aims to potentially improve the design of the CONNECT2 study.
PepGen confirmed that no new safety issues related to PGN-EDO51 have been observed since its last safety update as of January 23, 2025. The decision enables the company to focus resources on completing CONNECT1 and advancing its FREEDOM studies in myotonic dystrophy type 1.
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