Entrada Therapeutics announced on February 24, 2025, that the United States Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44. The FDA also authorized the initiation of ELEVATE-44-102, a Phase 1b multiple ascending dose (MAD) clinical study of ENTR-601-44 for adult Duchenne muscular dystrophy (DMD) patients amenable to exon 44 skipping.
The global ELEVATE-44 program, encompassing both the U.S. and ex-U.S. studies, will evaluate ENTR-601-44 in a broad population of DMD patients, including those with early and advanced disease, both ambulatory and non-ambulatory adults. The ELEVATE-44-102 study will enroll approximately 32 adult patients and assess safety, tolerability, target engagement, and pharmacokinetics.
Dosing for ELEVATE-44-102 will be administered every six weeks, with planned doses across four cohorts anticipated to range from 0.16 mg/kg up to 1.28 mg/kg. Entrada plans to initiate study enrollment in the first half of 2026, leveraging the strength of its safety and target engagement data from the Phase 1 clinical study.
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.