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Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44
ENTR-601-44, a proprietary Endosomal Escape Vehicle (EEV™)-conjugated phosphorodiamidate morpholino oligomer (PMO), is the lead product candidate within Entrada’s Duchenne muscular dystrophy franchise from its growing pipeline of EEV-therapeutics. Each EEV-PMO therapeutic candidate has an oligonucleotide sequence designed and optimized for ...
Entrada’s 2-year ordeal ends as FDA lifts hold on DMD drug
10 hours ago · While ENTR-601-44 was stuck in regulatory limbo in the U.S., Sarepta secured FDA approval for its DMD gene therapy Elevidys in 2023. RegenXBio is also advancing its own gene therapy prospect into ...
FDA Removes Clinical Hold on Duchenne Muscular Dystrophy Agent ENTR-601-44
1 day ago · The FDA has authorized a phase 1b study of ENTR-601-44 in adults with DMD amenable to exon 44 skipping. The study will evaluate safety, tolerability, target engagement, and pharmacokinetics in 32 patients. Participants may enter an open-label extension study to assess long-term safety, efficacy, and tolerability.
Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44
1 day ago · 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 ...
All statements, other than statements of historical facts, contained in this presentation, including statements regarding the Company's strategy, future operations, prospects and plans, objectives of management, the timing of regulatory filings for the planned Phase 2 clinical trials for ENTR-601-44 and ENTR-601-45 in the fourth quarter of 2024,...
Entrada Therapeutics Announces Updates on ENTR-601-44 in …
ENTR-601-44, an investigational therapy for the potential treatment of people living with Duchenne who are exon 44 skipping amenable, is being evaluated for its potential to restore the mRNA reading frame and allow for the translation of dystrophin protein that is slightly shortened but still functional.
Entrada announces FDA removal of clinical hold on ENTR-601-44
14 hours ago · 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 ...
Entrada Therapeutics | Entrada Therapeutics Announces Clinical …
The Company’s lead oligonucleotide programs include ENTR-601-44 targeting Duchenne muscular dystrophy (DMD) and ENTR-701 targeting myotonic dystrophy type 1 (DM1). For more information about Entrada, please visit our website, www.entradatx.com , and …
• ENTR-601-44 is a DMD exon 44–skipping PMO conjugated to the EEV platform and is currently being investigated for the treatment of exon 44 skip-amenable DMD. ENTR-601-44 has demonstrated exon skipping and dystrophin restoration in skeletal muscle cells derived from patients with DMD who have a DMD exon 44
FDA Clears Entrada Therapeutics' Early-Stage For Potential
11 hours ago · 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 ...
- Some results have been removed