FDA lifts clinical hold on Entrada's ENTR-601-44 for DMD Phase 1b study

Entrada Therapeutics, Inc.

FDA authorized ELEVATE-44-102, a Phase 1b multiple ascending dose study of ENTR-601-44 in adults with DMD amenable to exon 44 skipping.
Study targets ~32 non-ambulatory and ambulatory patients; doses from 0.16 to 1.28 mg/kg every six weeks.
Company also received UK MHRA authorization for ELEVATE-44-201; global program now covers pediatric and adult patients.
Plans to initiate enrollment in first half of 2026 with seamless transition to open-label extension.
CEO cites strength of Phase 1 safety/target engagement data and unmet need in adults living with Duchenne.

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