Entrada Therapeutics Announces Positive Results from the First Cohort of Participants with Duchenne Muscular Dystrophy (DMD) in the Phase 1/2 ELEVATE-45-201 Study of ENTR-601-45
Entrada Therapeutics reported positive Cohort 1 topline data from the Phase 1/2 ELEVATE-45-201 study of ENTR-601-45 in Duchenne patients amenable to exon 45 skipping. The 5 mg/kg dose met primary safety and tolerability objectives, with a 0.10% mean increase in dystrophin production (n=6, nominal p=0.03) and 0.15% increase in exon skipping versus baseline; all participants rolled into the open-label Phase 2 portion. Cohort 2 (10 mg/kg) enrollment is complete, with data expected in the first half of 2027, and the company expects meaningfully higher dystrophin production at escalated doses up to 15 mg/kg.
Key figures
- Drug Name
- ENTR-601-45
- Phase Of Trial
- Phase 1/2
- Dose cohort1
- 5 mg/kg
- Dosing schedule
- once every six weeks (Q6W)
- Dystrophin increase
- 0.10% mean increase vs baseline (p = 0.03)
- Exon45 population pct
- approximately 9% of DMD patient population
- Exon skipping increase
- 0.15% mean increase vs baseline
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