Entrada Therapeutics announced on March 24, 2025, that it received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate ELEVATE-45-201. This is a Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-45 for Duchenne muscular dystrophy (DMD) patients amenable to exon 45 skipping.
The company is on track to initiate ELEVATE-45-201 in Q3 2025. ELEVATE-45-201 is a global, two-part, randomized, double-blind placebo-controlled study designed to evaluate the safety, tolerability, and effectiveness of ENTR-601-45 in ambulatory DMD patients.
Part A of the study will assess safety, pharmacokinetics, and pharmacodynamics, including exon skipping and dystrophin production, in approximately 24 patients with planned doses ranging from 5 mg/kg up to 15 mg/kg. This marks the second clinical program in Entrada's Duchenne franchise to receive UK clearance, building on the momentum of the ELEVATE-44 program.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.