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Editas Medicine Announces Enrollment of the First Pediatric Cohort in the BRILLIANCE Clinical Trial of EDIT-101 for the Treatment of LCA10 Following IDMC Endorsement
IDMC endorsed proceeding with first pediatric cohort based on a review of clinical safety data from adult low-dose and adult mid-dose cohorts Concurrently
About this update from Editas Medicine, Inc.
[{"type":"text","content":"IDMC endorsed proceeding with first pediatric cohort based on a review of clinical safety data from adult low-dose and adult mid-dose cohorts Concurrently enrolling the adult high-dose cohort in the BRILLIANCE trial Company plans to report initial EDIT-101 clinical data in September CAMBRIDGE, Mass., June 23, 2021 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that centers are now enrolling the first of two planned pediatric cohorts in the Phase 1/2 BRILLIANCE clinical trial of EDIT-101 following the Independent Data Monitoring Committee (IDMC) endorsement to proceed. The IDMC endorsement is based on an analysis of safety data from the adult low-dose and adult mid-dose cohorts. The Company also announced the completion of dosing of the adult mid-dose cohort. Both the pediatric mid-dose cohort and the adult high-dose cohort will run concurrently. For both cohorts, first dosing is expected this summer and completion is expected in the first half of 2022. EDIT-101 is under development for the treatment of Leber congenital amaurosis 10 (LCA10). “We are extremely pleased with the endorsement of the IDMC, and we look forward to bringing EDIT-101 to additional patients in the BRILLIANCE trial. LCA10 is an early onset retinal degenerative disease resulting in significant vision loss and blindness. Positive feedback from the IDMC is a critical step to move to initiate EDIT-101 dosing in pediatric patients,” said Lisa Michaels, M.D., Executive Vice President and Chief Medical Officer, Editas Medicine. “I would like to thank all of the patients who have and will participate in this landmark gene editing medicine clinical trial. We are planning to report initial clinical data at a medical meeting this September.” “We have a long history at Mass. Eye and Ear of helping develop life-changing medicines, and we are pleased to be working at the forefront of research on this novel therapy. We are eager to begin studying EDIT-101 in pediatric patients where we believe it can have great impact and the potential to restore vision,” said Eric A. Pierce, M.D., Ph.D., Director of the Inherited Retinal Disorders Service and Director of the Ocular Genomics Institute at Massachusetts Eye and Ear, the William F. Chatlos Professor of Ophthalmology at Harvard Medical School, and a Principal Investi...