PepGen: FDA Lifts Clinical Hold On DM1 Program; Expects Cash Runway To Fund Operations Into 2025

(RTTNews) - PepGen Inc. (PEPG) announced the FDA has lifted the full clinical hold and cleared the company's Investigational New Drug Application to initiate the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 in the U.S. The company said 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.

PepGen 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 continues to expect its cash and cash equivalents to be sufficient to fund operations into 2025.

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