Entrada announces FDA removal of clinical hold on ENTR-601-44

Entrada Therapeutics (TRDA) announced that the United States Food and Drug Administration has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. The global ELEVATE-44 program, which includes the ELEVATE-44-102 study in the U.S. and ELEVATE-44-201 outside of the U.S., will cover a broad population of patients with DMD and support evaluation of ENTR-601-44 in patients with both early and advanced disease. ELEVATE-44-102 is a randomized, double-blind placebo-controlled Phase 1b study evaluating the safety and tolerability of ENTR-601-44 in approximately 32 non-ambulatory and ambulatory adult patients with DMD who are exon 44 skipping amenable. The MAD study is also designed to evaluate target engagement as measured by exon skipping and dystrophin production, and pharmacokinetics. Dosing will be administered every six weeks, with the planned doses across four cohorts anticipated to range from 0.16 mg/kg up to 1.28 mg/kg. Study participants may be eligible to enter an open label extension study, in which the safety, efficacy and tolerability of ENTR-601-44 will be evaluated over a longer period of time. The Company plans to initiate study enrollment in the first half of 2026, which would enable a seamless transition into an OLE.