礼来公布中和抗体联合疗法全新数据！向FDA提交紧急使用授权申请

2020-10-08 医药魔方医药魔方

10月7日，礼来宣布了其抗SARS-CoV-2病毒中和抗体开发项目的最新进展，包括两款中和抗体 LY-CoV555与LY-CoV016（从君实引进的JS016）的联合疗法用于新确诊轻至中度COVID-

10月7日，礼来宣布了其抗SARS-CoV-2病毒中和抗体开发项目的最新进展，包括两款中和抗体 LY-CoV555与LY-CoV016（从君实引进的JS016）的联合疗法用于新确诊轻至中度COVID-19患者的BLAZE-1研究最新期中数据。

BLAZE-1研究(NCT04427501)为一项随机、双盲、安慰剂对照、II期研究，主要评估LY-CoV555和LY-CoV016相比安慰剂用于治疗伴有症状COVID-19门诊患者的疗效及安全性差异，计划入选800例症状轻至中度且药物输注前3日内SARS-CoV-2样本检测为阳性的COVID-19患者。

该研究的单药治疗队列评估LY-CoV555三个剂量 (700，2800，7000 mg)的治疗效果和安全性，联合用药组评估LY-CoV555（2800mg）+ LY-CoV016（2800mg）的治疗效果和安全性。安慰剂组患者在完成各队列研究后允许进入全部受试药组交叉用药。研究主要终点是第11天SARS-CoV-2 病毒载量较基线的变化。其他终点包括因COVID-19住院的患者比例，29天内死亡率、安全性等。

截至期中分析时，联合疗法组入组112人，安慰剂对照组入组156人。结果显示，LY-CoV555+ LY-CoV016联合疗法显着降低了第11天的病毒载量（p=0.011），达到了该研究的主要终点。联合疗法还降低了第3天(p=0.016)及第7天(p<0.001)（感染过程中较早的时间点，通常能观察到更高的病毒载量）的病毒水平。该联合疗法亦达到预设的临床终点，包括自第1至11天的症状总体评分相较于基线的时间加权平均变化。探索性分析结果显示，联合疗法组第7天病毒载量依然较高的患者比例低于安慰剂对照组（3% vs 20.8%，p<0.0001）。联合疗法组COVID-19相关住院和急诊治疗的发生率低于安慰剂对照组（0.9% vs 5.8%），风险降低84.5%。

目前在接受联合疗法的患者中未观察到推测的耐药变异。联合疗法的耐受性良好，未发生与药物有关的严重不良事件(SAEs)，且治疗相关的紧急不良事件(TEAEs)与安慰剂相当。

礼来计划尽快在同行评议期刊上发表LY-CoV555单药疗法和LY-CoV555+LY-CoV016联合疗法的临床数据。

LY-CoV555是礼来与AbCellera公司合作开发的用于治疗和预防COVID-19的IgG1单克隆抗体，可以直接结合SARS-CoV-2的刺突蛋白，阻断病毒黏附和进入人宿主细胞，从而起到中和病毒的作用。LY-CoV016则是礼来从君实生物获得大中华区以外开发权益的一款重组全人源单克隆中和抗体，以高亲和力特异性结合SARS-CoV-2表面刺突蛋白受体结构域，并能有效阻断病毒与宿主细胞表面受体ACE2的结合。于IgG1抗体的Fc段引入点突变，以消除抗体依赖性增强作用(ADE)、抗体依赖性细胞介导的细胞毒性作用(ADCC)及抗体依赖性细胞吞噬作用(ADCP)等效应。

在中和抗体的生产和供应方面，对于LY-CoV555单药疗法，鉴于三种剂量LY-CoV555的临床效果相似，礼来基本确认将700mg作为临床治疗剂量，并期望在2020Q4能够供应100万剂700mg的LY-CoV555，其中10万剂在10月份保证供应。对于联合疗法，礼来期望2020Q4能够供应5万剂，之后随着产能扩大以及与Amgen在抗体生产方面建立的合作，供应量从2021Q1开始将会放大。

在未充分证明上述疗法可以作为COVID-19的具有临床意义的治疗选择前，礼来决定投入巨额资金放大抗体产能其实也承担了不小的商业风险，但这同时也是制药企业为了满足全球治疗需求而承担的一种社会责任。鉴于BLAZE-1研究中联合疗法的积极数据以及此前LY-CoV555单药治疗的数据，礼来已经与全球监管机构进行了密切沟通，并向FDA正式提出了将LY-CoV555单药疗法用于高风险的新确诊轻至中度COVID-19患者的紧急使用授权（EUA）申请。礼来计划在获得更多安全性数据和产能支持后于11月份向FDA提出 LY-CoV555+LY-CoV016联合疗法的EUA申请。礼来预计2021Q2可以获得支持其向FDA提交正式上市申请（BLA）的临床数据。

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2020-12-15 wincls

#联合疗法#

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2020-10-18 小天要好好生活

学习了

0 0
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2020-10-13 1581f8c42cm

好

113 0
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2020-10-11 1581f8c42cm

学习

105 0
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19:07:01 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891661, encodeId=af4a891661d1, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, createdName=1581f8c42cm, createdTime=Tue Oct 13 02:36:53 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891200, encodeId=81e389120014, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, 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2020-10-10 guguangxiang

#紧急#

31 0
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2020-10-09 小小车医生

抗体疗法，看到了新希望

98 0
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19:07:01 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891661, encodeId=af4a891661d1, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, createdName=1581f8c42cm, createdTime=Tue Oct 13 02:36:53 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891200, encodeId=81e389120014, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, 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style='color:#2F92EE;'>#礼来#</a>的使用了中国<a href='/topic/show?id=053a103902aa' target=_blank style='color:#2F92EE;'>#君实#</a>的中和抗体, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎), TopicDto(id=73910, encryptionId=60bfe391059, topicName=礼来), TopicDto(id=103902, encryptionId=053a103902aa, topicName=君实)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Fri Oct 09 03:14:09 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890671, encodeId=15078906e176, content=早日战胜疫情, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200910/7e96bbab0c5c420e8fe7846dcdd38c29/2b6be8f4b6284022a808d4f619b7aed6.jpg, createdBy=2aaa1602125, createdName=opzoro, createdTime=Fri Oct 09 01:49:04 CST 2020, time=2020-10-09, status=1, ipAttribution=)]
2020-10-09 12038f64m02暂无昵称

学习

96 0
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19:07:01 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891661, encodeId=af4a891661d1, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, createdName=1581f8c42cm, createdTime=Tue Oct 13 02:36:53 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891200, encodeId=81e389120014, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, 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createdAvatar=https://img.medsci.cn/20201005/1d700ea3e5d64796b793e9d314f7f99b/8df8d63541164ba594db35d1a06f45c1.jpg, createdBy=76aa2511113, createdName=小小车医生, createdTime=Fri Oct 09 10:17:01 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890696, encodeId=479c89069689, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201009/850075858cc4481aa22c247c691bc9b6/4a0a2f141a844cb2a0af4d9ae3c281b1.jpg, createdBy=10bd2163613, createdName=12038f64m02暂无昵称, createdTime=Fri Oct 09 08:18:54 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890673, encodeId=70ab8906e31f, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>，<a href='/topic/show?id=60bfe391059' target=_blank 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createdAvatar=https://img.medsci.cn/20200910/7e96bbab0c5c420e8fe7846dcdd38c29/2b6be8f4b6284022a808d4f619b7aed6.jpg, createdBy=2aaa1602125, createdName=opzoro, createdTime=Fri Oct 09 01:49:04 CST 2020, time=2020-10-09, status=1, ipAttribution=)]
2020-10-09 lovetcm

#新冠肺炎#，#礼来#的使用了中国#君实#的中和抗体

121 0
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19:07:01 CST 2020, time=2020-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891661, encodeId=af4a891661d1, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, createdName=1581f8c42cm, createdTime=Tue Oct 13 02:36:53 CST 2020, time=2020-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=891200, encodeId=81e389120014, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, 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style='color:#2F92EE;'>#礼来#</a>的使用了中国<a href='/topic/show?id=053a103902aa' target=_blank style='color:#2F92EE;'>#君实#</a>的中和抗体, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎), TopicDto(id=73910, encryptionId=60bfe391059, topicName=礼来), TopicDto(id=103902, encryptionId=053a103902aa, topicName=君实)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Fri Oct 09 03:14:09 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890671, encodeId=15078906e176, content=早日战胜疫情, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200910/7e96bbab0c5c420e8fe7846dcdd38c29/2b6be8f4b6284022a808d4f619b7aed6.jpg, createdBy=2aaa1602125, createdName=opzoro, createdTime=Fri Oct 09 01:49:04 CST 2020, time=2020-10-09, status=1, ipAttribution=)]
2020-10-09 opzoro

早日战胜疫情

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