Entrada advances highest-dose DMD trial cohort

• Entrada Therapeutics (NASDAQ:TRDA) will begin the highest-dose cohort in its Phase 1/2 ELEVATE-44-201 study evaluating ENTR-601-44 for Duchenne muscular dystrophy.
• An independent monitoring committee recommended advancing to an 18 mg/kg dose after reviewing safety and pharmacokinetic data from eight participants in Cohort 2.
• The trial is evaluating ENTR-601-44 in patients with DMD mutations amenable to exon 44 skipping.

Entrada Therapeutics (NASDAQ:TRDA) announced that an independent monitoring committee has recommended initiating Cohort 3 of its Phase 1/2 ELEVATE-44-201 clinical study.

The committee reviewed available safety information and pharmacokinetic data from eight participants enrolled in Cohort 2 and supported advancing the program to the highest planned dose level.

Cohort 3 will evaluate ENTR-601-44 at 18 mg/kg, following previous dose levels of 6 mg/kg in Cohort 1 and 12 mg/kg in Cohort 2.

ENTR-601-44 is being developed as a potential treatment for Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle weakness, in patients whose mutations are suitable for exon 44 skipping.

Entrada said Cohort 2 enrollment has been completed, with ongoing evaluation of safety, drug exposure, and treatment effects.

The company expects to report Cohort 1 data after one year of open-label treatment by the end of 2026, with Cohort 2 data expected in the first quarter of 2027.

Entrada Therapeutics focuses on developing RNA and genetic medicines using its Endosomal Escape Vehicle (EEV) technology platform to deliver therapeutic molecules into cells.