FDA lifts clinical hold on Entrada’s ENTR-601-44 study

25 February 2025

The US Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase Ib multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.

The drug is under development by Boston, USA-based Entrada Therapeutics (Nasdaq: TRDA), but has been held back for two years. Entrada also noted that this development follows a similar approval by the UK's Medicines and Healthcare Products Regulatory Agency for a related study.

The global ELEVATE-44 program, which includes the ELEVATE-44-102 study in the USA and ELEVATE-44-201 outside of the USA, will cover a broad population of patients with DMD and support evaluation of ENTR-601-44 in patients with both early and advanced disease, which is expected to kick off in the first half of 2026.

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