Item 7.01 |
Regulation FD Disclosure. |
On July 17, 2024, Adverum Biotechnologies, Inc. (the “Company”) updated its corporate presentation for use in meetings with investors, analysts and others. A copy of the corporate presentation is furnished as Exhibit 99.1 hereto.
The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information under this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
On July 17, 2024, the Company announced efficacy and safety results from the pre-specified 26-week interim analysis from the LUNA Phase 2 trial of Ixoberogene soroparvovec (Ixo-vec) in patients with wet age-related macular degeneration (AMD).
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, 6E10 or 2E11 vg/eye. The trial is designed to inform the selection of Ixo-vec dose(s) and corticosteroid prophylactic regimen(s) for Phase 3 registrational trials. In addition to assessing the two doses of Ixo-vec, LUNA is evaluating enhanced prophylactic regimens, with patients receiving one of two locally administered corticosteroid regimens, with or without oral prednisone.
As of the February 14, 2024 data cut-off date for the landmark interim analysis, 58 patients had completed the 26-week study visit, with two discontinuations related to adverse events unrelated to study drug. The trial was designed to assess a broad wet AMD population, including patients requiring frequent anti-vascular endothelial growth factor (VEGF) injections before enrolling in LUNA: at baseline, mean annualized prior anti-VEGF injections were 10.1 (2.6 SD), mean central subfield thickness was 350.6 (115.2 SD), and mean best corrected visual acuity (BCVA) was 72.3 (7.7).
At the interim analysis,100% (n=20) of patients receiving the difluprednate-alone prophylactic regimen have completed their prophylaxis regimen, enabling evaluation of this regimen.
As previously reported in February 2024, the Company implemented a protocol amendment to extend the Ozurdex®-containing regimens with a course of difluprednate drops. As a result of this protocol amendment extending prophylaxis beyond the 26-week interim analysis landmark for some patients, 35.6% of patients in the Ozurdex + difluprednate prophylactic arm have not completed the scheduled regimen as of the 26-week interim analysis data cut-off date, limiting the Company’s ability to fully evaluate this prophylactic arm at the interim analysis.
The LUNA trial builds on the Company’s experience with the OPTIC study, for which landmark 2-year data was published in The Lancet’s eclinicalmedicine and landmark 3-year data was presented at the American Academy of Ophthalmology 2023 Annual Meeting.
LUNA Efficacy and Safety Results from the Pre-Specified 26-week Interim Analysis
Both the 6E10 and 2E11 doses demonstrated maintenance of visual and anatomic outcomes. Notably, both doses resulted in a potentially best-in-class percentage of patients remaining free of anti-VEGF injections and reduction in annualized anti-VEGF injections, with data trending similar to or better than the OPTIC study.
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Treatment Burden Reduction |
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Ixo-vec demonstrated a significant proportion of patients injection free at both doses at week 26. |
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6E10: 76% of patients injection free (n=29) |
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2E11: 83% of patients injection free (n=29) |
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Ixo-vec demonstrated a significant reduction in mean annualized anti-VEGF injections at week 26. |
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6E10: 90% reduction in mean annualized anti-VEGF injections |
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2E11: 95% reduction in mean annualized anti-VEGF injections |
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Visual (BCVA) and Anatomic (CST) Outcomes: |
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Visual acuity was maintained at both dose levels – least squares mean BCVA change from baseline at week 26 (95% CI): |