Entrada: FDA Declines to Lift Hold on Duchenne Study

By Colin Kellaher

Entrada Therapeutics on Wednesday said the U.S. Food and Drug Administration declined to lift the clinical hold on a planned study of ENTR-601-44 as a potential treatment of Duchenne muscular dystrophy.

The Boston clinical-stage biopharmaceutical company said it is disappointed by the FDA's decision, citing the strength of a data package it submitted to the agency after the hold was implemented late last year.

Entrada said the information it submitted to the FDA supported the initiation of a Phase 1 study in the U.K. in September, and that it has completed dosing for the first and second cohorts in the study, with plans to announce data in the second half of 2024.

Entrada said it continues to plan for the global development of ENTR-601-44, adding that it will re-engage the FDA to discuss its next steps in due course.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

November 22, 2023 07:39 ET (12:39 GMT)

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