Ocugen基因疗法显示能显著减缓AMD继发地图状萎缩的疾病进展

Minhua笔记01-16

1月15日，美国生物技术公司Ocugen公布其AAV5基因疗法OCU410在ArMaDa II期试验的初步数据，显示该药显著减缓干性AMD继发GA病变进展。公司计划本季度公布完整数据，并于2026年启动III期试验，目标2028年提交上市申请。1月15日，Ocugen公布了ArMaDa II期临床试验的初步数据。该试验旨在研究其基因疗法OCU410治疗干性年龄相关性黄斑变性（AMD）继发地图状萎缩...

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II期试验的初步数据，显示该药显著减缓干性AMD继发GA病变进展。公司计划本季度公布完整数据，并于2026年启动III期试验，目标2028年提交上市申请。1月15日，Ocugen公布了ArMaDa II期临床试验的初步数据。该试验旨在研究其基因疗法OCU410治疗干性年龄相关性黄斑变性（AMD）继发地图状萎缩（GA）的疗效，希望在调节补体通路之外，为患者提供更多治疗选择。OCU410是一种AAV5基因疗法，可递送视黄酸相关孤儿受体α（RORA）。RORA是一种核受体，可调节参与视网膜健康的关键通路，包括氧化应激、炎症、脂质代谢和补体信号传导。现有的GA药物例如Apellis Pharmaceuticals的Syfovre（pegcetacoplan）和Astellas的Izervay（avacincaptad pegol）仅抑制补体系统，需要每月或隔月进行玻璃体内注射，Ocugen表示OCU410针对与该疾病相关的多个通路，可作为一次性疗法给药。这项II期研究将51名患者随机分为三组：一组接受单次200 µL视网膜下注射，分别含有5 × 10¹⁰ vg/mL（中剂量）或1.5 × 10¹¹ vg/mL（高剂量），以及一个未接受治疗的对照组。病灶生长减少46%来自中剂量组和高剂量组共23名患者的数据显示，与未接受治疗的对照组相比，12个月时病灶生长减少了46%。中等剂量组的疗效似乎优于高剂量组，与对照组相比，中等剂量组的病灶面积缩小了 54%，而高剂量组仅缩小了 36%。此外，接受治疗的患者中有一半的病灶面积缩小了 50% 以上，而未接受治疗的患者则没有这种效果；在 14 名基线病灶较大（≥7.5 mm²）的患者中，疗效更为显著，病灶面积缩小了 57%。去年 8 月公布的一项试验中期分析（基于 31 名患者的数据）显示，病灶生长速度减缓了 27%，并且视网膜组织得到了保护。更新还包括来自该试验I期部分的一些额外数据，其中包括接受OCU410治疗的眼睛在一年后椭圆体区（一种与感光细胞健康密切相关的关键视网膜结构）的丢失速度比未接受治疗的眼睛慢60%。“至关重要的是，我们对60名患者的安全性数据显示，迄今为止未出现与药物相关的严重不良事件、炎症信号或注射并发症，这表明该药物具有良好的风险获益比，”首席医疗官Huma Qamar表示。据该公司称，迄今为止，尚未报告任何与OCU410相关的眼内炎、视网膜脱离、血管炎、脉络膜新生血管或视神经缺血性病变病例。III 期临床试验计划Syfovre于2023年获得FDA批准用于治疗AMD继发的 GA，在最近一个季度财报中收入达1.51亿美元。该药此前曾因引发视网膜血管炎的风险而受到关注。与此同时，Izervay也于2023年在美国获批用于治疗相同适应症。然而，这两种药物在欧洲的申请均未获得成功；欧盟药物咨询委员会多次拒绝建议批准Syfovre，而安斯泰来在与同一欧盟委员会的讨论无果后，于2024年底主动撤回了Izervay的欧盟申请。尽管如此，该领域的研发者们并未停滞不前。今年10月，初创公司Cirrus Therapeutics获得1100万美元融资，用于研发其针对干性AMD的基因疗法，旨在通过增加免疫调节因子IRAK-M的表达来保护视网膜功能。Ocugen表示，计划在本季度晚些时候公布ArMaDa试验的完整数据，并于2026年启动III期临床试验，可能在2028年提交OCU410的上市申请。该公司股价当天下跌约14%。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":2,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; 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