Editas receives Australian approval to initiate Phase 1/2 Strive trial of EDIT-401 in HeFH

Editas Medicine, Inc.

Australia's TGA and HREC cleared the Phase 1/2 Strive trial of EDIT-401; a submission is also under review in New Zealand, with five trial sites selected across both countries.
Strive is two-part: Part 1 single ascending dose, open-label; Part 2 single-dose, randomized, placebo-controlled. Initial safety/tolerability data expected Q1 2027. Topline later in 2027.
Preclinical data showed ~90% or greater mean reduction in LDL-C, Lp(a) and ApoB in non-human primates; ~90% LDL-C reduction was maintained over 10 months.
Editas will present EDIT-401 durability data at AHA Scientific Sessions on Nov 8, 2026, in Chicago; CMO Dan Ory, M.D. is the presenter.
Editas remains on track to begin patient dosing in 2026 and plans to complete Part 1 enrollment with topline safety and efficacy results later in 2027.

This headline and bullets were generated automatically by deepseek-v4.1-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.