ENTR-601-45 - (ELEVATE-45-201)

August 5, 2026: Entrada Therapeutics (NASDAQ: TRDA) provided a multi-program clinical and regulatory update focused on Duchenne muscular dystrophy (DMD) and partnered DM1 program VX-670.

ENTR-601-44 / ELEVATE-44-201 (exon 44 DMD): Cohort 2 enrollment is complete in the global Phase 1/2 MAD study. Previously reported Cohort 1 met the primary objective of favorable safety/tolerability, with no discontinuations or serious adverse events, and showed early functional benefit in Time to Rise and Time to Rise velocity versus placebo. Cohort 1 open-label data (6 mg/kg) are expected by year-end 2026; Cohort 2 data (12 mg/kg) in Q1 2027; Cohort 3 may follow if needed. A long-term extension protocol (ENTR-DMD-202) was accepted by U.K. and European authorities. For ELEVATE-44-102, the company plans to re-engage FDA on raising the planned starting dose.

ENTR-601-45 / ELEVATE-45-201 (exon 45 DMD): Cohort 1 enrollment/dosing is complete. A DMC recommended starting Cohort 2 at 10 mg/kg without protocol changes after reviewing safety/PK from eight participants. Cohort 1 data (5 mg/kg) are expected in October 2026; Cohort 2 data in H1 2027.

ENTR-601-50 / ELEVATE-50-201: Received U.K. MHRA and Research Ethics Committee authorization to start a Phase 1/2 MAD study in exon 50 DMD.

ENTR-601-51: CTA-enabling studies are complete; global regulatory applications are planned after review of lead-program data.

VX-670 (Vertex-partnered, DM1): Enrollment is complete and dosing continues in the GALILEO Phase 1/2 MAD study, with data expected in H2 2026.