regulatory
confidence high
sentiment positive
materiality 0.60
Entrada gets UK MHRA nod for Phase 1/2 trial of DMD candidate ENTR-601-44
Entrada Therapeutics, Inc.
- UK MHRA and REC authorized ELEVATE-44-201, a global Phase 1/2 MAD study of ENTR-601-44 for DMD exon 44 skipping.
- Dosing every 6 weeks across three cohorts (6-18 mg/kg); Part A safety/PK/PD, Part B efficacy.
- Company on track to initiate trial in Q2 2025; regulatory filings also submitted in US and EU.
- Prior Phase 1 single-dose study showed ENTR-601-44 well-tolerated with no serious adverse events.
- If eligible, participants may enter an open-label extension for longer-term safety/efficacy assessment.