Entrada Announces Independent DMC, Per Study Protocol, Reviews All Safety And PK Data From Eight Patients Who Completed Dosing In Cohort 1 Of Double-Blinded, Placebo-Controlled, MAD Portion Of ELEVATE-44-201

-- Patients in Cohort 1 have progressed to the open label, Phase 2 portion of ELEVATE-44-201 --

-- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year --

BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (NASDAQ:TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available safety and PK data from the eight patients who completed dosing in Cohort 1 of the double-blinded, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-44-201. The DMC recommended initiation of Cohort 2 at 12 mg/kg, a dose escalation from 6 mg/kg in Cohort 1. ELEVATE-44-201 is a Phase 1/2 MAD clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.

ELEVATE-44-201 is a global, two-part, randomized, double-blind, placebo-controlled Phase 1/2 study evaluating the safety, tolerability and effectiveness of ENTR-601-44 in ambulatory patients with DMD who are exon 44 skipping amenable. The Company completed dosing of the MAD portion of the study for Cohort 1, and participants have transitioned to the 6-dose open label, Phase 2 portion of the study. The Company is on track to report data from Cohort 1 (6 mg/kg) in the second quarter of 2026, data from Cohort 2 (12 mg/kg) by year-end, and data from Cohort 3 (up to 18 mg/kg) to follow. The Company also intends to open an expansion cohort later in the year to increase the number of participants treated in the ELEVATE-44-201 study, as this study has been designed to support an accelerated approval in the U.S. In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44.