AAVantgarde Completes LUCE‑1 Trial Enrollment for AAVB‑081
AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company pioneering therapies for inherited retinal diseases (IRDs), has announced the completion of enrollment in LUCE-1, their Phase 1/2 first-in-human clinical trial evaluating AAVB-081 for the treatment of retinitis pigmentosa associated with Usher syndrome type 1B (USH1B).
LUCE-1 is a multicenter, open-label, dose-escalation and expansion study evaluating the safety, tolerability, and preliminary efficacy of a single subretinal administration of AAVB-081, AAVantgarde’s dual-AAV gene therapy program, targeting mutations in the MYO7A gene, and addressing the root cause of USH1B. The study enrolled 15 adult participants between 18 to 60 years of age.
Dr. Natalia Misciattelli, CEO of AAVantgarde, said:
Completing enrollment in the LUCE-1 study represents an important milestone in the clinical development of AAVB-081. We are grateful to the patients, investigators and clinical site staff whose commitment has enabled the rapid advancement of this program toward generating meaningful clinical data for individuals living with Usher syndrome type 1B.
Prof. Michaelides, from Moorfields Eye Hospital, said:
Dosing the final patient in the LUCE Phase 1/2 study marks a significant milestone for this programme and for the patients and families affected by this devastating inherited retinal condition. Early-phase clinical research is where scientific innovation begins to translate into real-world impact, and LUCE represents an important step toward the development of a potential disease-modifying therapy. We are grateful to the sites, patients and families who have participated and now look forward to the data that will guide the next stage of development.
AAVantgarde is making rapid progress on both of its clinical programs, and is recruiting in the CELESTE study for Stargardt disease. Usher 1B and Stargardt Disease are both debilitating inherited retinal conditions with no approved treatments currently available. Further updates for both programs to come in 2026.
