PepGen cleared by FDA to begin study of muscular dystrophy drug

Photo caption: A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Photo credit: Sarah Silbiger via Getty Images. Article by Kristin Jensen. BioPharma Dive – October 12, 2023.

Dive Brief:

• PepGen can start a Phase 1 study in the U.S. of a therapy for a rare form of muscular dystrophy after the Food and Drug Administration lifted a clinical hold on the program.
• The trial will include sites in both the U.S. and Canada, where regulators cleared the treatment for human testing in September. PepGen said Thursday it expects to release proof-of-concept data from the study, dubbed Freedom-DM1, next year
• The oligonucleotide-based therapy is designed to treat patients with myotonic dystrophy type 1, or DM1. […]

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