Entrada Therapeutics, Inc. (TRDA), a clinical-stage biopharmaceutical company, on Monday provided an update on its upcoming Phase 1/2 clinical trial for ENTR-601-44, a treatment for Duchenne muscular dystrophy or DMD in patients with exon 44 skipping amenable mutations.
The company announced it has received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency or MHRA to initiate the ELEVATE-44-201 study, a multiple ascending dose clinical trial.
The trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ENTR-601-44, including exon skipping and dystrophin production.
Pharmacokinetic data from previous studies showed promising results, with ENTR-601-44 being well tolerated in healthy volunteers, demonstrating significant plasma and muscle concentration, and showing exon skipping activity.
The Phase 1/2 study will enroll approximately 24 patients in part A, testing doses ranging from 6 mg/kg to 18 mg/kg.
Part B will further assess the optimal dose for safety and efficacy. The company is on track to initiate the study in Q2 2025.
Entrada Therapeutics is optimistic that ENTR-601-44 could provide an important new treatment for patients with DMD, a condition that currently has limited treatment options.
Currently, TRDA is trading at $13.58 up by 1.04%.
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