ENTR-601-45 - (ELEVATE-45-201)

June 2, 2026: Entrada Therapeutics, Inc. (NASDAQ: TRDA) reported that an independent Data Monitoring Committee reviewed all available safety and pharmacokinetic (PK) data from the eight participants in Cohort 1 of ELEVATE-45-201, a double-blind, placebo-controlled multiple ascending dose Phase 1/2 study of ENTR-601-45 for Duchenne muscular dystrophy (DMD) in patients with DMD gene mutations amenable to exon 45 skipping. Based on this review, the DMC recommended initiating Cohort 2 at 10 mg/kg, escalating from 5 mg/kg in Cohort 1. Participants in Cohort 1 have progressed to the open-label Phase 2 portion of the study.

ELEVATE-45-201 plans to enroll 24 ambulatory participants ages 4–20, dosing IV every six weeks across three cohorts anticipated to range from 5 mg/kg up to 15 mg/kg. The company said it is on track to report Cohort 1 safety and early PK and dystrophin data in mid-2026, with Cohort 2 (10 mg/kg) and Cohort 3 (up to 15 mg/kg) data to follow.