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REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update and Program Updates for RGX-314 for the Treatment of Wet AMD
ROCKVILLE, Md., Aug. 4, 2020 /PRNewswire/ -- Company on track to initiate RGX-314 subretinal delivery pivotal program by the end of 2020 RGX-314 was generally
About this update from Regenxbio Inc.
[{"type":"text","content":"ROCKVILLE, Md., Aug. 4, 2020 /PRNewswire/ -- \nCompany on track to initiate RGX-314 subretinal delivery pivotal program by the end of 2020 RGX-314 was generally well-tolerated in 42 patients at all dose levels in Phase I/IIa trial Positive interim update from Cohorts 4 and 5 at one year informs pivotal program Durable treatment effect observed with stable to improved visual acuity and retinal thickness Demonstrated meaningful reductions in anti-VEGF treatment burden over one year 61% and 85% reduction of anti-VEGF injections in Cohorts 4 and 5, respectively 73% of patients (8/11) in Cohort 5 remain anti-VEGF injection-free Intraocular RGX-314 protein expression levels are dose-dependent at one yearPhase II trial for RGX-314 for the treatment of wet AMD using suprachoroidal delivery (AAVIATE) is active Enrollment expected to begin in Q3 2020; interim data update from first cohort expected by end of 2020Company to host conference call and webcast on Tuesday, August 4 at 8:30a.m. ET, featuring wet AMD Key Opinion Leaders, Robert Avery, M.D., Dante Pieramici, M.D., and Peter Kaiser, M.D.REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today reported positive one year data from patients in Cohorts 4 and 5 of the Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). The Company plans to initiate a pivotal program for subretinal delivery of RGX-314 in patients with wet AMD by the end of 2020. In addition, REGENXBIO today announced that a Phase II trial of RGX-314 for the treatment of wet AMD delivered to the suprachoroidal space (AAVIATE) is active and expected to enroll patients in the third quarter of 2020.\n\"Today's results provide further evidence of the clinical profile of RGX-314 as a promising one-time gene therapy treatment paradigm for patients with wet AMD,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"The data demonstrated stable to improved visual acuity and retinal thickness, as well as a meaningful reduction in anti-VEGF injection burden, in these higher dose levels at one year. Results from the Phase I/IIa trial will inform the design of the pivotal program of RGX-314 in patients with wet AMD, which we look f...