Editas Medicine Receives Approval to Initiate First-In-Human Clinical Trial of EDIT-401 in Patients with Hyperlipidemia
Globe Newswire•08/10/2026•07:00 ET
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Key Highlights
- ➤EDIT-401 Phase 1/2 trial cleared to initiate dosing in HeFH patients in Australia
- ➤Editas expects first patient dosing this year and initial safety data in Q1 2027
- ➤EDIT-401 maintained approximately 90% LDL-C reduction over 10 months in primates
- ➤Part 1 topline safety and efficacy data expected later in 2027
Expert Statements
Dan Ory, Chief Medical Officer, Editas Medicine
“The receipt of regulatory and ethics approval for clinical trial initiation in Australia is a significant step in advancing the clinical development of EDIT-401, a potentially transformative in vivo gene editing medicine designed to upregulate LDLR expression and reduce LDL-C levels in patients living with hyperlipidemia. We look forward to initiating the Strive study and generating our first-in-human data as we advance EDIT-401 through key clinical milestones in 2027”
Dan Ory, Chief Medical Officer, Editas Medicine
“We are also encouraged by the new EDIT-401 preclinical data to be presented at AHA, which further support its potential to provide durable, lifelong benefits to patients.”
Phase 1/2 clinical trial of EDIT-401 cleared to initiate dosing in patients who require additional LDL-C lowering
Company remains on track to begin patient dosing this year and report initial safety and tolerability data in the first quarter of 2027
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