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REGENXBIO Announces Dosing of First Patient in Phase II AAVIATE™ Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery
- Interim data update from first cohort expected by end of 2020 - Targeted, in-office suprachoroidal delivery of RGX-314 using the SCS Microinjector® may
About this update from Regenxbio Inc.
[{"type":"text","content":"- Interim data update from first cohort expected by end of 2020\n - Targeted, in-office suprachoroidal delivery of RGX-314 using the SCS Microinjector® may provide additional administration options for patients with wet AMD\n\n\nROCKVILLE, Md., Sept. 9, 2020 /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 that the first patient has been dosed in the AAVIATE trial, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of wet age-related macular degeneration (wet AMD). The Company expects to report interim data from the first cohort of this trial by the end of 2020.\n\"The initiation of this trial is an important milestone for REGENXBIO, as it is the first clinical trial to evaluate the delivery of any gene therapy, including RGX-314, to the suprachoroidal space. RGX-314 has shown evidence of potentially meaningful treatment effect in patients with wet AMD when delivered subretinally in the ongoing Phase I/IIa trial, and we are excited about the potential of the targeted, in-office suprachoroidal approach, which may provide additional RGX-314 delivery options for patients. We look forward to providing additional updates from this trial later this year,\" said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO.\nAAVIATE is a multi-center, open-label, randomized, active-controlled, dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector, a targeted, in-office route of administration. The trial is expected to enroll approximately 40 patients with severe wet AMD across two cohorts. Patients in each cohort will be randomized to receive RGX-314 versus monthly 0.5 mg ranibizumab intravitreal injection at a 3:1 ratio, and two dose levels of RGX-314 will be evaluated: 2.5x1011 GC/eye and 5x1011 GC/eye. Patients will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RGX-314. \nThe primary endpoint of the trial is mean change in vision in patients dosed with RGX-314, as measured by best corrected visual acuity (BCVA), at Week 40 from baseline, compared to pati...