Entrada receives authorization in the UK for Phase I trial of ENTR-601-44

Entrada Therapeutics announced that it has received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency and Research Ethics Committee for its CTIMP for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable. The Phase 1 trial’s primary objective is to evaluate the safety of a single dose of ENTR-601-44 in healthy volunteers, with a target enrollment of approximately 40 participants. The trial will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle. The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.