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Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 10 mg/kg in Entrada Therapeutics' ELEVATE-45-201 Study

TRDA
  • Entrada Therapeutics announced that Cohort 1 participants in the ELEVATE-45-201 study have progressed to the open-label Phase 2 portion.
  • An independent Data Monitoring Committee reviewed safety & PK data from the eight Cohort 1 participants & recommended escalating the dose to 10 mg/kg for Cohort 2.
  • The ELEVATE-45-201 study is a Phase 1/2 trial evaluating ENTR-601-45 for Duchenne muscular dystrophy in patients with exon 45 skipping mutations.
  • The company expects to report Cohort 1 data in mid-2026, with Cohort 2 & Cohort 3 data to follow.
  • ENTR-601-45 utilizes a once-every-six-weeks dosing regimen to potentially reduce treatment burden while improving outcomes.
  • The study involves 24 ambulatory participants aged four to 20 years, with planned doses ranging from 5 mg/kg to 15 mg/kg across three cohorts.