-- Participants in Cohort 1 have progressed to the open-label, Phase 2 portion of ELEVATE-45-201 --
-- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026 --
BOSTON, June 02, 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 participants enrolled in Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-45-201. The DMC recommended initiation of the Cohort 2 dose at 10 mg/kg, a dose escalation from 5 mg/kg in Cohort 1. ELEVATE-45-201 is a Phase 1/2 MAD clinical study of ENTR-601-45 for the potential treatment of Duchenne muscular dystrophy (DMD) in participants with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
“We are pleased that after reviewing Cohort 1 data from our ELEVATE-45-201 study, the independent Data Monitoring Committee supports the initiation of Cohort 2 dosing at the increased dose of 10 mg/kg,” said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. “We look forward to sharing safety and early PK and dystrophin data from Cohort 1 of our ELEVATE-45-201 study in mid-2026. Importantly, with a dosing regimen of once every six weeks, ENTR-601-45 has the added potential to improve outcomes while decreasing the burden of treatment for people living with DMD who are exon 45 skipping amenable.”
About the ELEVATE-45-201 Phase 1/2 Study
ELEVATE-45-201 is a global, two-part, randomized, double-blind, placebo-controlled Phase 1/2 study evaluating the safety, tolerability and efficacy of ENTR-601-45 in 24 ambulatory participants ages four to 20 with Duchenne who are exon 45 skipping amenable. Dosing will be administered every six weeks, with the planned doses across three cohorts anticipated to range from 5 mg/kg up to 15 mg/kg. The multiple ascending dose (MAD) Part A portion of the study is evaluating the safety, pharmacokinetics, pharmacodynamics and functional parameters following intravenous administration of ENTR-601-45 to study participants in the U.K. and EU. Following the initial three doses administered in Part A, study participants continue receiving ENTR-601-45 in the Phase 2, open-label portion in which the safety and efficacy of ENTR-601-45 will be evaluated over a longer period of time. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 (10 mg/kg) and Cohort 3 (up to 15 mg/kg) to follow.
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About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. 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-45-201 study, including planned dosing levels, the timing of data from Entrada’s Phase 1/2 MAD clinical study of ENTR-601-45 including safety and early PK and dystrophin data from Cohort 1 in mid-2026, and Cohort 2 and Cohort 3 to follow, the ability to recruit for and complete the global Phase 2 clinical study for ENTR-601-45 including both the randomized, double-blind, placebo controlled and open-label portions of the study, the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-45 to improve outcomes and decrease the burden of treatment for people living with DMD who are exon 45 skipping amenable including a dosing regimen of once every six weeks, and the continued development and advancement of ENTR-601-45 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.
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