Trial Profile

A Phase 1 Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of PGN-EDODM1 in Adult Participants With Myotonic Dystrophy Type 1 (FREEDOM-DM1)

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 13 Jun 2025

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At a glance

03 Jun 2025 Planned End Date changed from 1 Apr 2025 to 1 Oct 2025.
03 Jun 2025 Planned primary completion date changed from 1 Apr 2025 to 1 Jun 2025.
28 May 2025 According to a Pepgen Corporation media release, company expect to report data from its FREEDOM-DM1 15 mg/kg cohort in patients with DM1 during the second half of 2025 and company expects to report data from the 5 mg/kg cohort of its FREEDOM2-DM1 study in DM1 patients in the first quarter of 2026.

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