Entrada Therapeutics, Inc. (TRDA) reported that its independent Data Monitoring Committee reviewed safety and pharmacokinetic data from eight patients who completed dosing in Cohort 1 of the ELEVATE‑44‑201 Phase 1/2 study and recommended initiation of Cohort 2 at a 12 mg/kg dose.
The ELEVATE‑44‑201 study is a global, randomized, double‑blind, placebo‑controlled Phase 1/2 trial evaluating ENTR‑601‑44 in ambulatory patients with Duchenne muscular dystrophy amenable to exon 44 skipping. The company stated it is on track to report Cohort 1 data in the second quarter of 2026 and Cohort 2 data by year‑end, with a planned Cohort 3 at up to 18 mg/kg to follow.
This DMC endorsement is significant because it clears the company to expand dosing, potentially accelerating the path to regulatory submission and demonstrating the safety profile of its Endosomal Escape Vehicle platform in a critical patient population. The decision also signals progress toward the company’s goal of delivering a clinically meaningful exon‑skipping therapy before its cash runway reaches a critical threshold.
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