Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 3 at the Top Dose of 18 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study
Cohort 2 enrollment is complete, with its data expected in Q1 2027 following the Cohort 1 open-label update.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Entrada Therapeutics (TRDA) announced an independent monitoring committee’s recommendation to initiate the highest-dose cohort in its Phase 1/2 ELEVATE-44-201 study.
The committee reviewed available safety and pharmacokinetic data, measuring drug exposure, from eight Cohort 2 participants. It recommended 18 mg/kg for Cohort 3, following 12 mg/kg in Cohort 2 and 6 mg/kg in Cohort 1. The study evaluates ENTR-601-44 for Duchenne muscular dystrophy in participants whose mutations are amenable to exon 44 skipping. Cohort 2 enrollment is complete. Entrada expects Cohort 1 data after one year of open-label treatment by year-end 2026 and Cohort 2 data in Q1 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointIndependent committee recommended Cohort 3 at 18 mg/kg, following doses of 12 mg/kg and 6 mg/kg.
- Minor pointCohort 2 enrollment is complete, with eight participants enrolled.
- Minor point. Forward-looking: it has not happened yet and may not happen.Entrada expects Cohort 1 open-label data by year-end 2026 after one year of treatment.
- Minor point. Forward-looking: it has not happened yet and may not happen.Entrada expects Cohort 2 data in Q1 2027.
Negative
- None.
Details
Market Reaction – TRDA
On Oct 14, the day this news came out, the latest delayed price for TRDA is 0.41% above the previous close. The latest delayed price is $4.88. Relative volume is exceptionally heavy at 6.9x the average.
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Key Figures
- Cohort 3 dose
- 18 mg/kg
- Top dose recommended by the DMC
- Cohort 2 dose
- 12 mg/kg
- Prior cohort dose
- Cohort 1 dose
- 6 mg/kg
- Prior cohort dose
- Participants reviewed
- 8 participants
- Cohort 2 safety and PK data
- Cohort 1 data timing
- By year-end 2026
- After the open-label period
- Cohort 2 data timing
- Q1 2027
- Enrollment complete; data expected
Key Terms
pharmacokinetics medical
pharmacodynamics medical
multiple ascending dose medical
oligonucleotide medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- Company to receive ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 --
-- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 --
BOSTON, Oct. 14, 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 2 of the double-blind, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-44-201. The DMC recommended initiating Cohort 3 at the top dose of 18 mg/kg, an increase from 12 mg/kg in Cohort 2 and 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 participants with a confirmed mutation in the DMD gene amenable to exon 44 skipping.
“The independent Data Monitoring Committee’s recommendation to advance to Cohort 3 at the top dose of 18 mg/kg marks another important step in the clinical development of ENTR-601-44,” said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. “This recommendation allows us to continue dose escalation in the ELEVATE-44-201 clinical study and deepen our understanding of ENTR-601-44’s safety, pharmacokinetic and pharmacodynamic profile, as dosing at 18 mg/kg could lead to meaningfully higher exposure, dystrophin production and functional benefit. We look forward to receiving data later this year from Cohort 1 participants after one year of treatment in the open-label period, followed by Cohort 2 data in the first quarter of 2027.”
About the ELEVATE-44-201 Phase 1/2 Study
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 participants aged four to 20 with Duchenne who are amenable to exon 44 skipping. 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-601-44 to study participants in three cohorts at sites in the U.K. and EU.
About ENTR-601-44
ENTR-601-44 is a proprietary Endosomal Escape Vehicle (EEV™)-conjugated oligonucleotide that has a sequence designed and optimized for people with a confirmed mutation in the DMD gene that is amenable to exon 44 skipping, which comprises approximately eight percent of the Duchenne patient population globally. ENTR-601-44 is designed to address the underlying cause of Duchenne, facilitating production of functional dystrophin from the endogenous (naturally occurring) DMD gene.
In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44.
Patients and Their Care Partners
Patients and their care partners are a critical part of our community, and we are committed to keeping them informed and connected. To receive community updates in real time and read today’s update, please visit Community Updates on our corporate website.
About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy (DMD) is a rare disease caused by mutations in the DMD gene, which encodes the dystrophin protein. These mutations lead to inadequate dystrophin production. Dystrophin is essential to maintaining the structural integrity and function of muscle cells. Lack of functional dystrophin leads to progressive loss of muscle strength, impacting mobility and causing heart or respiratory complications that contribute to high mortality rates. An estimated 41,000 people in the U.S. and Europe are living with DMD. Of those, approximately 11,500 are amenable to skipping of exon 44, 45, 50, or 51.
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 Entrada’s ELEVATE-44-201 study, including the timing of receiving data later this year from Cohort 1 participants after one year of treatment in the open-label period, the timing of data from Cohort 2 expected in Q1 2027, the potential for dose escalation in the ELEVATE-44-201 study to deepen Entrada’s understanding of ENTR-601-44’s safety, pharmacokinetic and pharmacodynamic profile and functional benefits and the ability of the MAD Part A portion of the study to evaluate the safety, pharmacokinetics, pharmacodynamics and functional parameters of ENTR-601-44, expectations regarding ENTR-601-44, including the ability for dosing at 18 mg/kg to lead to meaningfully higher exposure, dystrophin production and functional benefit, and the potential for ENTR-601-44 to address the underlying cause of DMD, facilitating production of functional dystrophin from the endogenous (naturally occurring) DMD gene, the potential therapeutic benefits of Entrada’s EEV product candidates, including and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and the partnered product candidate VX-670 for the potential treatment of DM1, the ability to continue to expand and develop additional therapeutic programs and modalities, including the potential treatment of neuromuscular and inherited retinal diseases, 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
Doug Snow
Head of Investor Relations
dsnow@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
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What dose did the monitoring committee recommend for Entrada’s ELEVATE-44-201 Cohort 3?
The independent committee recommended initiating Cohort 3 at 18 mg/kg, the study’s top dose. The recommendation followed review of available safety and pharmacokinetic data from eight Cohort 2 participants. Cohort 2 used 12 mg/kg, while Cohort 1 used 6 mg/kg.
Who is eligible for Entrada’s ELEVATE-44-201 study?
ELEVATE-44-201 evaluates ENTR-601-44 in ambulatory participants aged four to 20 with Duchenne muscular dystrophy and mutations amenable to exon 44 skipping. The randomized, double-blind, placebo-controlled Phase 1/2 study evaluates safety, tolerability and effectiveness; its multiple-dose Part A uses intravenous administration at sites in the U.K. and EU.