# PepGen cleared by FDA to begin study of muscular dystrophy drug

- Link: https://www.widthness.com/pepgen-cleared-by-fda-to-begin-study-of-muscular-dystrophy-drug/
- Published: 2023-10-15T09:30:12-05:00
- Author: Curated by Theresa Wysocki

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. […] Click here to view original web page at www.biopharmadive.com