Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 10 mg/kg in Entrada Therapeutics’ ELEVATE-45-201 Study
Rhea-AI Summary
Entrada Therapeutics (Nasdaq: TRDA) reported that an independent Data Monitoring Committee reviewed safety and PK data from eight participants in Cohort 1 of the Phase 1/2 ELEVATE-45-201 study of ENTR-601-45 for Duchenne muscular dystrophy.
The committee recommended initiating Cohort 2 at an escalated dose of 10 mg/kg, up from 5 mg/kg. Participants from Cohort 1 have progressed to the open-label Phase 2 portion, and Entrada remains on track to share Cohort 1 safety, PK and dystrophin data in mid-2026.
Positive
- Data Monitoring Committee backs dose escalation to 10 mg/kg in Cohort 2
- All eight Cohort 1 participants advanced to open-label Phase 2 portion
- Company targets mid-2026 for Cohort 1 safety, PK and dystrophin data readout
- Once-every-six-weeks dosing regimen may reduce treatment burden, per company
Negative
- None.
News Market Reaction – TRDA
In the Jun 2 session, TRDA declined 3.91%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 07 | Q1 2026 results | Positive | -57.3% | Q1 2026 results and positive ELEVATE‑44‑201 Cohort 1 topline data. |
| May 07 | DMD trial data | Positive | -57.3% | Positive topline Phase 1/2 ELEVATE‑44‑201 Cohort 1 ENTR‑601‑44 results. |
| May 06 | Data timing update | Neutral | -57.3% | Announcement of planned May 7, 2026 topline ELEVATE‑44‑201 readout. |
| Mar 02 | Inducement grants | Neutral | +1.5% | RSU inducement grants to two new non‑executive employees. |
| Feb 26 | FY 2025 results | Neutral | +6.8% | Q4 and full‑year 2025 results with DMC support for 12 mg/kg dose. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive Duchenne data and earnings updates have coincided with sharp negative reactions, indicating a pattern of market skepticism toward otherwise constructive clinical and financial milestones.
Over the past few months, Entrada reported multiple key updates. On Feb 26, 2026, it detailed Q4 2025 results and noted a DMC recommendation to escalate ELEVATE‑44‑201 Cohort 2 to 12 mg/kg, with $295.7 million in cash and a runway into Q3 2027. On May 7, 2026, positive topline Cohort 1 ELEVATE‑44‑201 data and Q1 2026 results, including $254.9 million in cash, were followed by a 57.27% drop. Today’s DMC-backed dose escalation for ENTR‑601‑45 continues this theme of advancing Duchenne programs amid volatile reactions.
Key Terms
data monitoring committee medical
multiple ascending dose medical
phase 1/2 medical
duchenne muscular dystrophy medical
exon 45 skipping medical
placebo-controlled medical
open-label medical
pharmacokinetics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
-- 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.
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 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.
Investor Contact
Kory Wentworth
Chief Financial Officer
kwentworth@entradatx.com
Patient Advocacy Contact
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Head of Patient Advocacy
patientadvocacy@entradatx.com
Media Contact
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CTD Comms, LLC
megan@ctdcomms.com
