Entrada Therapeutics, announced that the United States 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 (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. [Read More: Upcoming Exon 44 Skipping Therapies]
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. [Read More: What is exon skipping?]
Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44
- Receives FDA authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 in adults living with Duchenne muscular dystrophy.
- Follows recently received Medicines and Healthcare Products Regulatory Agency authorization in the United Kingdom for ELEVATE-44-201.
- Expands global ELEVATE-44 clinical program to include pediatric, adult, ambulatory and non-ambulatory patients with Duchenne muscular dystrophy.
The Company plans to initiate study enrollment in the first half of 2026, which would enable a seamless transition into an OLE.
Learn More: Potential Upcoming New Gene Therapies for Duchenne Muscular Dystrophy
