Clinical-stage company Adverum Biotechnologies has unveiled new nonclinical data supporting the two doses of its ixoberogene soroparvovec product being assessed by the Phase 2 LUNA trial, as well as proposing the potential for staggered, bilateral administration to treat wet age-related macular degeneration (AMD). Wet AMD is a bilateral eye condition affecting roughly 10% of AMD patients, with up to 42% of such cases leading to neovascularization—the creation of new blood vessels—in the second eye two to three years following diagnosis in the primary eye. Non-human primate studies suggested one intravitreal dose of ixo-vec could provide therapeutic benefits in the second eye, with no observed adverse effects in animals treated at the human equivalent dose of 2E11.
Presenting the findings at the recent Association for Research in Vision and Ophthalmology Annual Meeting in New Orleans, Adverum’s chief scientific officer Brigit Riley said: “The nonclinical data presented today support the two doses we are evaluating in the ongoing LUNA trial of Ixo-vec for the treatment of wet AMD, both in terms of tolerability and aflibercept levels within the targeted therapeutic range.” The study analyzed the effects of administering a dose of the product over time, given the incidence of bilateral nAMD. The data suggested peaks in therapeutic aflibercept protein levels in a second eye were within range, while the product was well tolerated and showed no signs of increased inflammation. No adverse effects were seen in animals at the human equivalent dose of 2E11, supporting the ongoing Phase 2 LUNA study of ixo-vec in wet AMD.
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The disease is expected to affect 288 million people globally by 2040, including 20 million people who currently live with it, with wet AMD set to represent around 10% of cases, according to Adverum. Wet AMD can lead to blindness in people aged over 65, and ixo-vec is being developed as a one-time IVT injection in a physician’s office, with the hope that it will reduce the need for frequent injections of anti-vascular endothelial growth factor (VEGF), and improve patient outcomes. The product uses a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Aflibercept targets a protein called vascular endothelial growth factor, which is instrumental in the proliferation of new blood vessels that play a key role in nAMD.
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