Adverum Biotechnologies Announces Positive Preliminary Efficacy and Safety Data from LUNA Phase 2 Trial of Ixo-vec in Patients with Wet AMD - Seite 2

Dr. Fischer continued, “Going into LUNA, we also looked to establish that an enhanced prophylactic regimen combined with highly active doses of Ixo-vec would further enhance its long-term benefit-risk profile. With these early data, we are pleased with the promising profile of Ozurdex plus difluprednate which we expect to be our go-forward regimen. We look forward to sharing the maturing LUNA dataset with the goal of confirming the optimal dose(s) and prophylactic regimen for pivotal studies and with the plan to present our 26-week interim analysis in the middle of 2024.”

“Based on my experience as an investigator for over five years across multiple clinical trials with Ixo-vec for wet AMD, it’s promising to see the sustained disease control and a significant treatment burden reduction after a single intravitreal injection of Ixo-vec in previously treated patients with wet AMD,” said Arshad M Khanani, M.D., M.A., FASRS, Managing Partner and Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno and Principal Investigator in LUNA trial. “Ixo-vec has the potential to shift the treatment paradigm for patients with wet AMD and I look forward to working with the Adverum team to advance Ixo-vec into pivotal studies.”

LUNA Trial Background and Baseline Demographics

The LUNA trial is an ongoing double-masked, randomized, Phase 2 trial. 60 patients with wet AMD were enrolled equally across two dose cohorts, 2E11 and 6E10 vg/eye. The study is designed to assess optimized prophylactic regimens, with patients receiving one and/or two locally administered corticosteroid regimens, with or without oral prednisone.

The LUNA trial builds on our experience with the OPTIC study, where landmark 2-year data was recently published in The Lancet’s eclinicalmedicine.

The data cut-off for these data is November 15, 2023, except for treatment burden reduction, which is of January 2, 2024.

LUNA Preliminary Efficacy and Safety Data Summary

Both the 2E11 and 6E10 doses demonstrated maintenance of visual and anatomic outcomes. Notably, both doses resulted in a potentially best-in-class reduction in annualized anti-vascular endothelial growth factor (VEGF) injections and the percentage of patients remaining free of annualized injections, with data trending similar to or better than the OPTIC study.