Clinical TrialMay 26, 2026, 06:12 AM
Editas Medicine EDIT-401 Preclinical Data Shows ~90% LDL-C Reduction; Plans Human Trial
AI Summary
Editas Medicine presented new preclinical data for EDIT-401 at the 94th European Atherosclerosis Society Congress, demonstrating robust reductions of approximately 90% or greater in LDL-C, Lp(a), and ApoB in non-human primates. The company plans to submit a Clinical Trial Notification in Australia by mid-2026 to initiate a first-in-human clinical trial for EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia later in 2026, with early human proof-of-concept data expected by year-end. Editas Medicine also received positive pre-IND feedback from the U.S. FDA, supporting its clinical development strategy.
Key Highlights
- EDIT-401 achieved a 90% or greater mean reduction in LDL-C in non-human primates.
- EDIT-401 achieved approximately 90% mean reduction in Lp(a) in non-human primates.
- EDIT-401 achieved approximately 90% mean reduction in ApoB in non-human primates.
- Reductions in LDL-C, Lp(a), and ApoB were durable through six months.
- Company plans to submit a Clinical Trial Notification (CTN) in Australia by mid-2026.
- First-in-human clinical trial for EDIT-401 in HeFH patients expected later in 2026.
- Early in vivo human proof-of-concept data for EDIT-401 expected by end of 2026.
- Received positive pre-IND feedback from the US FDA for EDIT-401.
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