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（纳斯达克：ADVM）发布了其正在进行的LUNA 2期IXO-VEC治疗湿性年龄相关性黄斑变性（AMD）的数据。
The 26-week interim analysis was presented at the American Society of Retinal Specialists Annual Meeting.
此26周中期分析在美国视网膜专家协会年会上展示。
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly ADVM-022), its clinical-stage gene therapy product candidate, for wet AMD.
Adverum正在开发IXOBEROGENE SOROPARVOVEC（即ADVm-022），其临床阶段基因治疗产品候选者，用于治疗湿性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发布了正在进行的LUNA 2期试验中有关湿性AMD患者的初步安全性和疗效数据。
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试验招募了60名湿性AMD患者，分为两个剂量组，6E10或2E11vg/眼，以确定第3期试验的设计。
As of the February 14, 2024 data cut-off, 58 patients had completed the 26-week visit.
截至2024年2月14日的数据截止日，58名患者已完成26周的随访。
The interim analysis showed significant reductions in anti-VEGF injections and maintenance of visual and anatomic outcomes.
中期分析显示注射抗VEGF的显著减少和视觉和解剖结果的维持。
Both dose levels resulted in a high percentage of patients remaining injection-free and significant reductions in mean annualized anti-VEGF injections.
两个剂量水平都导致高比例的患者保持无注射状态和平均年化抗VEGF注射量的显著减少。
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剂量的29名患者中，26周后有76％的患者没有注射过，而2E11剂量的患者中则为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剂量上观察到平均年化抗VEGF注射量的90％降低，而2E11剂量为95％。
Visual acuity and Fluid control were maintained at both dose levels.
在两个剂量水平上，视力和液体控制都得到了维持。
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，没有与药物有关的严重不良事件发生。
Enhanced corticosteroid prophylaxis in LUNA demonstrated an improved inflammatory profile compared to OPTIC.
在LUNA中增强的皮质类固醇预防措施展示了改善的炎症状况，相较于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.
患者偏好调查显示，88%的患者更喜欢Ixo-vec而不是之前的治疗方法，如果他们有双侧疾病，93%的患者将选择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预计将继续与FDA和EMA进行监管互动，并在2024年第四季度提交9个月的LUNA分析，并更新第3期试验设计。第3期试验的启动计划为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.
价格行动：ADVm在盘前曾一度飙升至11.64美元/股，截至上周三最后一次查询时，股价下跌了4.37％，为8.53美元/股。
- Why Is Eye Disease-Focused Adverum Bio Stock Trading Higher Today?
- 为什么以眼病为重点的Adverum Bio股票今天交易更高？