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REGENXBIO Presents Interim Data from Phase II Bridging Study Evaluating the Clinical Performance of RGX-314 Using the NAVXpress™ Manufacturing Platform Process
RGX-314 produced by the NAVXpress platform process has been well-tolerated and demonstrated a similar clinical profile to the initial adherent cell culture
About this update from Regenxbio Inc.
[{"type":"text","content":"RGX-314 produced by the NAVXpress platform process has been well-tolerated and demonstrated a similar clinical profile to the initial adherent cell culture processNAVXpress platform process is incorporated in the two ongoing pivotal trials and is expected to be used for future commercialization of RGX-314; the two pivotal trials are expected to support BLA submission in 2024Company to host live webcast with wet AMD Key Opinion Leaders to discuss new interim Phase II bridging study data, today, Saturday, February 11, at 11:30 a.m. ETROCKVILLE, Md., Feb. 11, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced results from a Phase II bridging study evaluating the pharmacodynamics, safety and efficacy of RGX-314, a potential one-time therapy delivered subretinally using cGMP material produced by the company's NAVXpress™ bioreactor platform process. The data is being presented at the Angiogenesis, Exudation, and Degeneration 2023 Conference by Charles C. Wykoff, M.D., PhD., Director of Research at Retina Consultants of Texas; Chairman of Research, Retina Consultants of America; and Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital.\n\"The interim results observed in the Phase II bridging study show a similar clinical profile between our manufacturing processes. We believe our approach, focused on early product quality and process control, allows us to efficiently transition from clinical trials to commercial readiness,\" said Curran Simpson, Chief Operating Officer of REGENXBIO. \"This update provides validation of our plans for the NAVXpress platform process to support the production of RGX-314 in anticipation of future commercialization.\"\n\"There is a significant need for treatment options that can reduce the burden of frequent injections for wet AMD patients while maintaining optimal function and anatomic outcomes,\" said Dr. Wykoff. \"The clinical profile of RGX-314 manufactured using the commercial-scale process is encouraging, as is the potential of a one-time therapy for the treatment of wet AMD.\"\nInterim Data Summary from the Phase II Bridging Study of RGX-314 using Subretinal DeliveryThe Phase II bridging study is designed to evaluate RGX-314 using subretinal delivery across two dose levels (6.4x1010 GC/eye and 1.3x1011 GC/eye) in 60 patients with wet AMD. At each dose...