Entrada Therapeutics (NASDAQ: TRDA) has received authorization from the UK's MHRA to initiate ELEVATE-45-201, a Phase 1/2 multiple ascending dose clinical study for ENTR-601-45 in Duchenne muscular dystrophy (DMD) patients amenable to exon 45 skipping.
The study is structured in two parts: Part A will evaluate safety, pharmacokinetics, and pharmacodynamics in approximately 24 patients across three cohorts, with doses ranging from 5 mg/kg to 15 mg/kg administered every six weeks. Part B will further assess the optimal dose established in Part A. Study participants may be eligible for an open-label extension study.
The company plans to initiate the study in Q3 2025. ELEVATE-45 represents the second of three Duchenne programs Entrada expects to advance into global clinical development in 2025, with regulatory filings already submitted in the EU.
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