Adverum Releases Interim Data From Gene Therapy Study For Blindness Disorder, Prepares For Pivotal Study
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).
Adverum Biotechnologies股份有限公司（納斯達克：ADVM）發佈了其正在進行的LUNA 2期IXO-VEC治療溼性年齡相關性黃斑變性（AMD）的數據。
The 26-week interim analysis was presented at the American Society of Retinal Specialists Annual Meeting.
此26週中期分析在美國視網膜專家協會年會上展示。
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly ADVM-022), its clinical-stage gene therapy product candidate, for wet AMD.
Adverum正在開發IXOBEROGENE SOROPARVOVEC（即ADVm-022），其臨床階段基因治療產品候選者，用於治療溼性AMD。
In February, Adverum Biotechnologies released preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet AMD.
今年2月，Adverum Biotechnologies發佈了正在進行的LUNA 2期試驗中有關溼性AMD患者的初步安全性和療效數據。
The LUNA trial enrolled 60 patients with wet AMD across two dose cohorts, 6E10 or 2E11 vg/eye, to inform Phase 3 trial designs.
LUNA試驗招募了60名溼性AMD患者，分爲兩個劑量組，6E10或2E11vg/眼，以確定第3期試驗的設計。
As of the February 14, 2024 data cut-off, 58 patients had completed the 26-week visit.
截至2024年2月14日的數據截止日，58名患者已完成26周的隨訪。
The interim analysis showed significant reductions in anti-VEGF injections and maintenance of visual and anatomic outcomes.
中期分析顯示注射抗VEGF的顯著減少和視覺和解剖結果的維持。
Both dose levels resulted in a high percentage of patients remaining injection-free and significant reductions in mean annualized anti-VEGF injections.
兩個劑量水平都導致高比例的患者保持無注射狀態和平均年化抗VEGF注射量的顯著減少。
Among 29 patients who received the 6E10 dose, 76% were injection-free after 26 weeks, with 83% for the 2E11 dose.
在接受6E10劑量的29名患者中，26周後有76％的患者沒有注射過，而2E11劑量的患者中則爲83％。
At the 6E10 dose, a 90% reduction in mean annualized anti-VEGF injections was observed, compared to 95% for the 2E11 dose.
在6E10劑量上觀察到平均年化抗VEGF注射量的90％降低，而2E11劑量爲95％。
Visual acuity and Fluid control were maintained at both dose levels.
在兩個劑量水平上，視力和液體控制都得到了維持。
Notably, Ixo-vec was well tolerated, with no serious adverse events related to the drug.
值得注意的是，IXO-VEC耐受性良好，沒有與藥物有關的嚴重不良事件發生。
Enhanced corticosteroid prophylaxis in LUNA demonstrated an improved inflammatory profile compared to OPTIC.
在LUNA中增強的皮質類固醇預防措施展示了改善的炎症狀況，相較於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.
患者偏好調查顯示，88%的患者更喜歡Ixo-vec而不是之前的治療方法，如果他們有雙側疾病，93%的患者將選擇Ixo-vec。
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.
Adverum預計將繼續與FDA和EMA進行監管互動，並在2024年第四季度提交9個月的LUNA分析，並更新第3期試驗設計。第3期試驗的啓動計劃爲2025年下半年。
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.
價格行動：ADVm在盤前曾一度飆升至11.64美元/股，截至上週三最後一次查詢時，股價下跌了4.37％，爲8.53美元/股。
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