Benzinga - by Vandana Singh, Benzinga Editor.
Adverum Biotechnologies Inc (NASDAQ:ADVM) released preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet age-related macular degeneration (AMD).
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.
Among the 60 patients in the trial, no serious adverse events tied to the gene therapy were reported.
When looking at treatment burden reduction at 26 weeks, ixo-vec demonstrated an annualized reduction in anti-vascular endothelial growth factor (anti-VEGF) injection rates of 90% among the 19 patients in the 6E10 cohort and 94% of the 20 patients in the 2E11 arm.
At 26 weeks, ixo-vec demonstrated injection-free rates of 68% for the 6E10 group and 85% of the patients in the 2E11 cohort.
On the efficacy side, Ixo-vec gene therapy maintained visual acuity and anatomic endpoints measuring central subfield thickness (CST).
Preliminary data suggest corticosteroid prophylaxis optimization at both the 2E11 and 6E10 doses appears to have improved inflammatory profiles in the LUNA study compared to OPTIC study results.
The company says that the LUNA 26-week interim analysis is expected in mid-2024, with the initiation of the Phase 3 trial expected in the first half of 2025.
Earlier this week, rival companies 4D Molecular Therapeutics (NASDAQ:FDMT) and Regenxbio Inc (NASDAQ:RGNX) released data from their respective wet AMD investigational therapies.
On Monday, Adverum Biotechnologies agreed to sell approximately 106.25 million shares in a $127.5 million private placement.
Adverum anticipates the gross proceeds from the private placement to be approximately $127.5 million and is expected to be sufficient to fund the current operating plan into late 2025.
Price Action: ADVM shares are down 20.60% at $2.23 on the last check Thursday.
Photo by Amanda Dalbjörn on Unsplash
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