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Independent Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 12 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study
Globenewswire· 2026-02-17 12:00
Core Insights - Entrada Therapeutics has progressed patients in Cohort 1 to the open label, Phase 2 portion of the ELEVATE-44-201 study, with data from Cohort 1 expected in Q2 2026 and Cohort 2 data by the end of the year [1][2] Company Overview - Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines that target intracellular mechanisms previously deemed inaccessible [3] - The company utilizes its proprietary Endosomal Escape Vehicle (EEV™) technology to enhance the delivery of therapeutics, aiming to improve treatment outcomes for various diseases, including neuromuscular disorders [3] Clinical Study Details - ELEVATE-44-201 is a Phase 1/2 clinical study evaluating the safety and effectiveness of ENTR-601-44 for treating Duchenne muscular dystrophy (DMD) in patients with specific gene mutations [1][2] - The study has completed dosing for Cohort 1 at 6 mg/kg and is set to escalate to 12 mg/kg for Cohort 2, with plans for a third cohort at doses up to 18 mg/kg [1][2] - The FDA granted Rare Pediatric Disease Designation to ENTR-601-44 in December 2025, which may facilitate accelerated approval processes [2]