regulatory
confidence high
sentiment positive
materiality 0.55
Entrada receives UK authorization for Phase 1/2 trial of ENTR-601-45 in DMD exon 45 skipping
Entrada Therapeutics, Inc.
- UK MHRA and Research Ethics Committee clearance to start ELEVATE-45-201, a Phase 1/2 MAD study of ENTR-601-45.
- On track to initiate the trial in Q3 2025; Part A will evaluate doses 5–15 mg/kg every 6 weeks in ~24 patients.
- Second Duchenne program (after ELEVATE-44); regulatory filings also submitted in the EU with review ongoing.
- Study is randomized, double-blind, placebo-controlled with a Part B for optimal dose evaluation and an OLE.
- CEO states strategy to run UK/EU studies first, then share data with FDA to enable U.S. registrational studies.