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Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate ELEVATE-44-201, a Phase 1/2 Multiple Ascending Dose Clinical Study of ENTR-601-44 in Patients Living with Duchenne Muscular Dystrophy
– Company on track to initiate ELEVATE-44-201 in Q2 2025 – – ENTR-601-44 regulatory filings submitted in additional geographies including the U.S. and EU,
About this update from Entrada Therapeutics, Inc.
[{"type":"text","content":"– Company on track to initiate ELEVATE-44-201 in Q2 2025 – – ENTR-601-44 regulatory filings submitted in additional geographies including the U.S. and EU, with regulatory discussions ongoing – BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced it had received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee for its Clinical Trial of an Investigational Medicinal Product to initiate ELEVATE-44-201, a Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. “The clearance by the MHRA marks a new phase in Entrada’s growth and, most importantly, moves us closer to realizing our commitment to families living with Duchenne muscular dystrophy,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “As the first authorization for our global MAD clinical study of ENTR-601-44 in patients, we are pleased to be initiating the study at what we believe to be an effective therapeutic dose. This is even more important since families living with Duchenne do not have time on their side as the progressive decline in function profoundly impacts the quality of life for patients and their care partners. It is this urgency that drives our work each day.” “The MHRA authorization of ELEVATE-44-201 is an exciting development in the clinical progress of ENTR-601-44, a new and very encouraging treatment option for boys and young men living with Duchenne muscular dystrophy who are exon 44 skipping amenable,” said Francesco Muntoni, MD, Professor of Paediatric Neurology. “There is a significant unmet medical need in this population, with limited therapeutic options available. The unique properties of Entrada’s EEV-therapeutic candidates offer the potential to provide tangible benefits for people with this life-shortening disease.” ELEVATE-44-201 is a global, two-part, randomized, double-blind placebo-controlled Phase 1/2 study evaluating the safety, tolerability and effectiveness of ENTR-601-44 in ambulatory patients with DMD who are exon 44 skipping amenable. Part A is a multiple ascending dose study designed to evaluate the safety, pharmacokinetics, and pharm...