FREEDOM-OLE

• Research type

  Research Study

• Full title

  An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants with Myotonic Dystrophy Type 1 (FREEDOM-OLE)

• IRAS ID

  1012250

• Contact name

  Hayley Parker

• Contact email

  clinreg@pepgen.com

• Sponsor organisation

  PepGen Inc.

• Research summary

  The purpose of this study is to learn about the long-term effects of an “investigational” medicine, PGN-EDODM1, and to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) .

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  25/NE/0123

• Date of REC Opinion

  21 Aug 2025

• REC opinion

  Further Information Favourable Opinion