-- 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.
“We are pleased that after reviewing the Cohort 1 data from our ELEVATE-44-201 study, the independent Data Monitoring Committee supports the initiation of Cohort 2 dosing at an increased dose of 12 mg/kg,” said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. “Because Entrada’s neuromuscular programs all leverage the same Endosomal Escape Vehicle, we are confident that this study progression substantially de-risks our clinical programs and marks a significant clinical inflection point for our company. Establishing that ENTR-601-44 is safe at 6 mg/kg is a clear milestone for the program. We expect our Cohort 1 data at 6 mg/kg to show double-digit dystrophin production when we disclose the data in the second quarter. As we dose escalate to 12 mg/kg, we believe we will achieve best-in-class dystrophin restoration with the readout of our Cohort 2 data later this year.”
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.
About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular, ocular and other diseases, leveraging next-generation EEVs, novel oligonucleotide sequences and an advanced protein engineering platform. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.
For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.
Forward-Looking Statements
This press release contains express and implied forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding planned Cohort 2 and Cohort 3 of Entrada’s ELEVATE-44-201 study, the timing of data from Entrada’s 1/2 MAD clinical study of ENTR-601-44 including Cohort 1 in the second quarter of 2026, Cohort 2 by year-end, and Cohort 3 to follow, the ability of Entrada to open an expansion cohort for ELEVATE-44-201 in 2026, the ability to recruit for and complete the global Phase 2 clinical study for ENTR-601-44, the ability of Entrada’s ELEVATE-44-201 study to support an accelerated approval in the U.S., the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, for Cohort 1 data at 6 mg/kg to show double-digit dystrophin and to achieve best-in-class dystrophin restoration with the dose escalation to 12 mg/kg for Cohort 2 with the data readout for Cohort 2 later this year, the ability for the ELEVATE-44-201 study progression to substantially de-risk our clinical programs, and the continued development and advancement of ENTR-601-44 for the treatment of DMD, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release.
Investor Contact Karla MacDonald Chief Corporate Affairs Officer kmacdonald@entradatx.com Patient Advocacy Contact Sarah Friedhoff Head of Patient Advocacy patientadvocacy@entradatx.com Media Contact Megan Prock McGrath CTD Comms, LLC megan@ctdcomms.com
