Regenxbio Completes Dosing of Fourth Cohort in Phase 1 Trial of RGX-314 Gene Therapy for Wet AMD

Source: Regenxbio

Regenxbio announced it has completed dosing of the fourth cohort of six patients in a phase 1 clinical trial evaluating RGX-314 for the treatment of wet age-related macular degeneration (AMD). A total of 24 subjects have been dosed in the trial. The company also announced that an updated summary of phase 1 study results, including additional study results for the first three cohorts since its previously reported interim results, are to be presented at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting in Chicago.

“We are thrilled with our progress in the clinical development of our lead product candidate, RGX-314, and pleased to have completed dosing of subjects in the fourth cohort at a higher dose,” Stephen Yoo, MD, Chief Medical Officer of Regenxbio, said in a company news release. “Wet AMD is a leading cause of irreversible blindness and visual impairment in the world. We continue to be encouraged by the positive interim data for RGX-314 and the potential of NAV AAV8 gene therapy as a one-time treatment for wet AMD.”

Jeffrey Heier, MD, Co-President and Director of Retina Research at Ophthalmic Consultants of Boston, and primary investigator for the trial, will be presenting study results during the “First-time Results of Clinical Trials” section entitled “26 Week Results of the Phase I Study to Evaluate Safety & Tolerability of RGX-314 Gene Therapy in nAMD Subjects” at 5:08 PM (CST) on Friday October 26th during the Retina Subspecialty Day program of AAO 2018.

Seven leading retinal surgery centers across the United States are participating in the phase 1 trial of RGX-314. This multicenter, open-label, multiple-cohort, dose-escalation clinical trial is designed to assess the safety and tolerability of RGX-314 as a one-time therapy for patients with previously treated wet AMD.

For further details on the trial, enrollment criteria and eligibility, contact patientadvocacy@regenxbio.com or visit https://clinicaltrials.gov/ct2/show/NCT03066258.


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