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Entrada Therapeutics Advances Duchenne Study to Highest Dose Level Following Safety Review

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TRDA$4.86 −11.64%

Entrada Therapeutics, Inc. (NASDAQ: TRDA) announced that an independent Data Monitoring Committee recommended starting Cohort 3 at the highest dose of 18 mg/kg in its Phase 1/2 ELEVATE-44-201 study. The decision follows a review of safety and pharmacokinetic data from eight participants in Cohort 2. The trial tests ENTR-601-44, an investigational treatment for Duchenne muscular dystrophy in participants with exon 44 skipping mutations.

Moving to the 18 mg/kg dose allows the company to continue dose escalation from 6 mg/kg in Cohort 1 and 12 mg/kg in Cohort 2. Higher dosing aims to increase drug exposure, dystrophin production, and potential functional benefit for patients. ENTR-601-44 targets the underlying cause of Duchenne muscular dystrophy, a progressive condition affecting an estimated 41,000 people across the United States and Europe.

Investors will watch for initial clinical trial readouts over the coming months. Entrada expects to receive one-year open-label data from Cohort 1 participants by the end of 2026, while data from Cohort 2 is anticipated in the first quarter of 2027. Shares of Entrada Therapeutics fell 11.64% to $4.86 in recent trading.

Key points

  • An independent monitoring committee recommended advancing Entrada Therapeutics' study to a top dose of 18 mg/kg.
  • The recommendation follows a safety and pharmacokinetic data review of eight participants in Cohort 2.
  • Initial trial data from Cohort 1's open-label period is expected by the end of 2026.
  • Data from Cohort 2 is projected for release in the first quarter of 2027.

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Questions and answers

What was recommended for Entrada Therapeutics' ELEVATE-44-201 study?

An independent committee recommended advancing the Phase 1/2 ELEVATE-44-201 trial to Cohort 3 at the top dose of 18 mg/kg after reviewing safety and pharmacokinetic data from Cohort 2.

When will Entrada Therapeutics release clinical data for ENTR-601-44?

Entrada expects to receive open-label period data from Cohort 1 by the end of 2026, followed by trial data from Cohort 2 in the first quarter of 2027.