REGENXBIO completes dosing for Phase 1/2a wet AMD trial


 REGENXBIO (NASDAQ:RGNX) has completed dosing in its Phase 1/2a trial of RGX-314 for the treatment of wet age-related macular degeneration (AMD).

RGX-314 uses REGENXBIO’s proprietary NAV gene delivery platform to transfer a vector encoding an antibody fragment that inhibits vascular endothelial growth factor (VEGF). RGX-314 is a one-time subretinal injection that prevents proliferation of leaky blood vessels that lead to retinal fluid accumulation and vision loss in wet AMD.

The trial, being conducted across eight U.S. retinal surgery centers, includes 42 subjects previously treated with anti-VEGF injections, across five escalating doses.

“Patients with wet AMD require intravitreal injections every four to 12 weeks, on average, [as] the current standard of care,” Dr. Steve Pakola, REGENXBIO’s CMO, said in a statement.

“We were pleased to report durable treatment response from cohort 3 of the RGX-314 Phase 1/2a trial for wet AMD at one year after a single administration of RGX-314 in a heavily pre-treated patient population,” he added.

Based on the Phase 1/2a data, REGENXBIO is planning to initiate a Phase 2b trial in wet AMD by the end of 2019.

Sydney Stewart