Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate Phase 1 Clinical Trial of ENTR-601-44 for the Potential Treatment of Duchenne Muscular Dystrophy

– First participant is expected to be dosed in September 2023 with data anticipated in the second half of 2024 –

– Cash runway extended through the end of 2025 –

Fueled by CureDuchenne’s funding, Entrada announced this morning an achievement in Duchenne muscular dystrophy treatment. Authorization from the MHRA and REC in the UK has been granted to initiate a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. This treatment, focused on exon 44 skipping, holds the potential to benefit individuals with Duchenne who are amenable:

BOSTON, Aug. 01, 2023 (GLOBE NEWSWIRE) — Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that it has received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its CTIMP (Clinical Trial of an Investigational Medicinal Product) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.

“We are looking forward to this important next step in advancing ENTR-601-44 for the potential treatment of people with exon 44 skipping amenable Duchenne muscular dystrophy, where there exists a profound unmet medical need,” said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics. “This milestone, coupled with the extension of our cash runway through the end of 2025, positions Entrada to advance our Duchenne franchise while broadening the potential of our intracellular therapeutics across serious diseases.”

The Phase 1 trial’s primary objective is to evaluate the safety of a single dose of ENTR-601-44 in healthy volunteers, with a target enrollment of approximately 40 participants. The trial will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle. The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.

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