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REGENXBIO Announces Completion of Dosing for Phase I/IIa Clinical Trial of RGX-314 in Wet AMD
ROCKVILLE, Md., May 30, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through
About this update from Regenxbio Inc.
[{"type":"text","content":"ROCKVILLE, Md., May 30, 2019 /PRNewswire/ -- 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 announced it completed dosing across all five cohorts in the Phase I/IIa clinical trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). \n\"We are excited to announce this important clinical milestone as we continue to drive the development of RGX-314 as a potential one-time gene therapy for patients with wet AMD,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. \"Patients with wet AMD require intravitreal injections every four to 12 weeks, on average, with the current standard of care. We were pleased to report durable treatment response from Cohort 3 of the RGX-314 Phase I/IIa trial for wet AMD at one year after a single administration of RGX-314 in a heavily pre-treated patient population in our interim trial update earlier this month,\" added Dr. Pakola. \"We look forward to providing top-line data, including from Cohorts 4 and 5, in the Phase I/IIa trial by the end of the year.\"\nEight leading retinal surgery centers across the United States are participating in the Phase I/IIa trial of RGX-314, designed to evaluate the safety and tolerability of RGX-314 as a one-time therapy for patients with wet AMD who were previously treated with anti-vascular endothelial growth factor (VEGF) injections. The trial includes 42 dosed subjects across five escalating dose cohorts. Each subject received a single dose of RGX-314 administered by subretinal delivery. \n\"The sustained clinical durability of effect seen one year after one-time administration of RGX-314 in Cohort 3 demonstrates the potential of RGX-314 to provide foundational anti-VEGF therapy that may sustain vision gains and alleviate treatment burden for millions of patients suffering from wet AMD,\" added Robert Avery, M.D., trial investigator and retina surgeon from California Retina Consultants. \nREGENXBIO is planning to initiate a Phase IIb trial in wet AMD by the end of 2019 based on the Phase I/IIa trial data and expand clinical development of RGX-314 by filing an Investigational New Drug (IND) application for diabetic retinopathy (DR) in the second half of 2019. \nAbout the P...