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Entrada Therapeutics Reports Positive Early Data for ENTR-601-45

MixedMedium impact
TRDA$4.86 −11.64%

Entrada Therapeutics (TRDA) reported favorable safety and preliminary efficacy results from Cohort 1 of its Phase 1/2 ELEVATE-45-201 study evaluating ENTR-601-45. In the initial trial group receiving 5 mg/kg intravenous doses, the treatment met its primary objectives for safety and tolerability. Despite the clinical results, shares of the company declined 11.64% to 4.86 USD.

The double-blind study showed that treated participants experienced a 0.10% mean increase in dystrophin levels compared to a 0.02% mean decrease in the placebo group after three doses. Treated participants also demonstrated a 0.15% mean increase in exon skipping compared to a 0.04% decrease for placebo. Laboratory evaluations showed no renal safety signals or hypomagnesemia, with eGFR, cystatin C, and magnesium levels staying within normal ranges.

Dosing is currently underway for Cohort 2 at a dose of 10 mg/kg. The company remains on track to report topline data for Cohort 2 in the first half of 2027, before advancing to Cohort 3 at doses up to 15 mg/kg.

Key points

  • Entrada Therapeutics (TRDA) met primary safety and tolerability goals in Cohort 1 of its Phase 1/2 ELEVATE-45-201 trial at 5 mg/kg.
  • Treated participants achieved a 0.10% mean increase in dystrophin and a 0.15% mean increase in exon skipping after three doses.
  • No hypomagnesemia or renal safety issues were observed, with eGFR, cystatin C, and magnesium levels in normal ranges.
  • Cohort 2 dosing at 10 mg/kg is ongoing, with data expected in the first half of 2027 prior to starting Cohort 3.
  • Entrada Therapeutics shares dropped 11.64% to 4.86 USD following the announcement.

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Questions and answers

What were the Phase 1/2 trial results for Entrada Therapeutics candidate ENTR-601-45?

Cohort 1 met primary safety and tolerability goals at 5 mg/kg. Treated participants achieved a 0.10% mean increase in dystrophin and a 0.15% mean increase in exon skipping after three doses, with no kidney or magnesium safety issues.

When will Entrada Therapeutics report Cohort 2 trial data?

The company is on track to report topline data for Cohort 2 in the first half of 2027, followed by Cohort 3 dosing up to 15 mg/kg.

How did Entrada Therapeutics stock move after the trial results?

Entrada Therapeutics (TRDA) shares fell 11.64% to 4.86 USD following the Phase 1/2 data release.