Editas Wins Approval to Begin EDIT-401 Trial After Preclinical LDL-C Reduction of About 90%

Key Facts

Editas Medicine announced on October 8, 2026, that the Strive trial had received approval from a human research ethics committee and completed trial notification with Australia’s Therapeutic Goods Administration, allowing Phase 1/2 to begin in Australia. The study is testing EDIT-401, an investigational in vivo gene-editing therapy targeting the LDLR gene to increase expression of a protein associated with lower LDL cholesterol. The company designed the trial to assess the therapy’s safety, tolerability and efficacy after a single dose. The first part will use an open-label dose-escalation and dose-selection design, after which the program will move to a second, placebo-controlled randomized part. The approval moves the program into human testing, while the available results on the therapy’s effects remain based on preclinical studies in nonhuman primates.

The company said preclinical data showed an average reduction of about 90% or more in LDL-C, Lp(a) and ApoB in nonhuman primates. In an ongoing study, LDL-C remained down by about 90% for 10 months, according to its statement. The company also presented data showing that average reductions in Lp(a) and ApoB reached about 90% and persisted for three months in an ongoing study in nonhuman primates. These results remain part of the preclinical evidence presented by the company, while Strive is designed to test safety, tolerability and efficacy in humans. Chief Executive Gilmore O’Neill said the company looked forward to conducting the study and generating additional data in 2027.

Editas selected five clinical sites in Australia and New Zealand and submitted the study for review in New Zealand. The company said patients in both countries could enroll if it receives New Zealand approval. On timing, the company expects to announce initial safety and tolerability data in the first quarter of 2027. It also plans to complete enrollment in the first, dose-selection part and make initial safety and efficacy results available later in 2027. This is the announced path from dose selection to an initial trial readout during the coming year.

Editas shares, traded under the ticker EDIT, closed at $2.57 on November 6, 2026. The closing data provide an indication of the share price in the latest session cited in the information available for this story. The session’s trading range could not be confirmed from a reliable open source, so no verified high or low figures are available here. The available information also does not include a price more recent than the November 6 close. The clinical milestones announced for 2027 remain the company’s next specified dates for data related to the EDIT-401 program.