Entrada Therapeutics Inc. has announced it received authorization from health authorities and ethics committees in the European Union to commence ELEVATE-45-201, a Phase 1/2 multiple ascending dose clinical study. This study will focus on ENTR-601-45, targeting patients with Duchenne muscular dystrophy who are amenable to exon 45 skipping. The trial, expected to begin in the third quarter of 2025, aims to evaluate the safety, tolerability, and effectiveness of the therapy in ambulatory patients. The study is structured in two parts: Part A will assess safety and pharmacokinetics in approximately 24 patients, while Part B will further examine the optimal dose for safety and efficacy. Participants may also have the opportunity to join an open label extension study for extended evaluation. This initiative follows recent authorizations for similar studies, ELEVATE-44 and ELEVATE-45, with plans to file for ELEVATE-50 later in the year.
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