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(RTTNews) - Entrada Therapeutics, Inc. (TRDA), on Monday announced that it has received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency or MHRA and Research Ethics Committee to initiate its Phase 1/2 clinical trial, ELEVATE-45-201.

This study will evaluate ENTR-601-45, an investigational therapy for Duchenne muscular dystrophy or DMD, specifically targeting patients with mutations in the DMD gene amenable to exon 45 skipping.

The Phase 1/2 trial will be a two-part, randomized, double-blind placebo-controlled study.

Part A will involve a multiple ascending dose or MAD design in approximately 24 patients to assess the safety, pharmacokinetics, pharmacodynamics, and exon skipping effects of ENTR-601-45.

Part B will evaluate the optimal dose for safety and efficacy, including functional outcomes and patient-reported quality of life measures.

Entrada is on track to initiate ELEVATE-45-201 in Q3 2025, with the trial expected to advance globally.

This clinical program is part of the company's growing Duchenne pipeline, which includes multiple exon-skipping therapies targeting exon 44, 45, 50, and 51.

ENTR-601-45 is an Endosomal Escape Vehicle or EEV-conjugated phosphorodiamidate morpholino oligomer or PMO designed to restore the mRNA reading frame in DMD patients, potentially enabling the production of a functional, albeit shortened, dystrophin protein.

Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscle weakness and degeneration.

The disease is caused by mutations in the DMD gene, leading to insufficient dystrophin production, a crucial protein for muscle integrity.

With ELEVATE-45-201, Entrada aims to advance a novel therapeutic approach for those living with DMD and bring closer the potential for effective treatments targeting the underlying cause of the disease.

Currently, TRDA is trading at $10.80 up by 2.95 percent on the Nasdaq.

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