Adverum Releases Interim Data From Gene Therapy Study For Blindness Disorder, Prepares For Pivotal Study
Adverum Biotechnologies Inc (NASDAQ:ADVM) released data from its ongoing LUNA Phase 2 trial for Ixo-vec in patients with wet age-related macular degeneration (AMD).
The 26-week interim analysis was presented at the American Society of Retinal Specialists Annual Meeting.
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly ADVM-022), its clinical-stage gene therapy product candidate, for wet AMD.
In February, Adverum Biotechnologies released preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet AMD.
The LUNA trial enrolled 60 patients with wet AMD across two dose cohorts, 6E10 or 2E11 vg/eye, to inform Phase 3 trial designs.
As of the February 14, 2024 data cut-off, 58 patients had completed the 26-week visit.
The interim analysis showed significant reductions in anti-VEGF injections and maintenance of visual and anatomic outcomes.
Both dose levels resulted in a high percentage of patients remaining injection-free and significant reductions in mean annualized anti-VEGF injections.
Among 29 patients who received the 6E10 dose, 76% were injection-free after 26 weeks, with 83% for the 2E11 dose.
At the 6E10 dose, a 90% reduction in mean annualized anti-VEGF injections was observed, compared to 95% for the 2E11 dose.
Visual acuity and Fluid control were maintained at both dose levels.
Notably, Ixo-vec was well tolerated, with no serious adverse events related to the drug.
Enhanced corticosteroid prophylaxis in LUNA demonstrated an improved inflammatory profile compared to OPTIC.
The Patient Preference Survey revealed that 88% of patients would prefer Ixo-vec over prior treatments, and 93% would opt for Ixo-vec in the fellow eye if they had bilateral disease.
Adverum anticipates continued regulatory interactions with the FDA and EMA, presenting the 9-month LUNA analysis in Q4 2024 and updating the Phase 3 trial design. The initiation of the Phase 3 trial is planned for H1 2025.
Price Action: ADVM reached as high as $11.64 during the premarket and now is trading 4.37% lower at $8.53 at the last check on Wednesday.
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