Entrada Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) 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. ENTR-601-44 is the company’s proprietary Endosomal Escape Vehicle (EEV
)-conjugated phosphorodiamidate morpholino oligomer (PMO), for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.
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., 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 adults with Duchenne who are exon 44 skipping amenable. The study will also explore exon skipping, dystrophin production, and pharmacokinetics of ENTR-601-44.
According to Entrada, study participants may be eligible to enter an open label extension study (OLE), 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.
Read Entrada’s press release here.
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