肝脏安全问题促使强生公司放弃BACE抑制剂atabecestat的研发

2018-05-20 MedSci MedSci原创

强生公司表示,将终止对晚发性临床前阶段阿尔茨海默病患者开发BACE抑制剂atabecestat的研发。该公司指出,这一决定是在某些接受该药物的患者中观察到肝酶升高后决定的,这些肝酶问题是“性质严重”的

强生公司表示,将终止对晚发性临床前阶段阿尔茨海默病患者开发BACE抑制剂atabecestat的研发。该公司指出,这一决定是在某些接受该药物的患者中观察到肝酶升高后决定的,这些肝酶问题是性质严重的。

强生公司指出,在评估阿塔珠司研究的所有可用肝脏安全性数据后,得出的结论是,效益-风险比不再有利。该制药商补充说,正在停止atabecestatIIb / III期早期研究中对迟发性临床前阶段阿尔茨海默病和II期长期安全性试验的研究。

BACE1(一种分泌酶)是参与生成淀粉样蛋白 β多肽 (Aβ)的关键酶,该β多肽沉积于阿尔茨海默氏病 (AD)相关的胞外淀粉样斑块中。上个月,JanssenFujirebio签署了一项协议,开发和销售一种检测方法,以帮助识别可能从atabecestat治疗中获益的患者。今年早些时候,在外部数据监测委员会得出结论认为,如果试验继续进行,BACE1抑制剂不太可能表现出积极的益处/风险比,同时MerckCo.也结束了用于治疗阿尔茨海默病治疗的verubecestat的第三阶段研究。


原始出处:

http://www.firstwordpharma.com/node/1566577?tsid=28®ion_id=2#axzz5G0R8oY75

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    2019-03-16 shanyongle
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encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Wed Sep 19 11:50:00 CST 2018, time=2018-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2051148, encodeId=d8d720511488a, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Thu Aug 02 05:50:00 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1984739, encodeId=fb331984e398a, content=<a href='/topic/show?id=c52a501e787' target=_blank style='color:#2F92EE;'>#强生公司#</a>, beContent=null, objectType=article, channel=null, 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href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466053, encodeId=88cd146605354, content=<a href='/topic/show?id=217c292009' target=_blank style='color:#2F92EE;'>#ATA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2920, encryptionId=217c292009, topicName=ATA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387a6772119, createdName=bbjsj_1981, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587534, encodeId=8ce6158e53408, content=<a href='/topic/show?id=d1201843d5' target=_blank style='color:#2F92EE;'>#ACE抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1843, encryptionId=d1201843d5, topicName=ACE抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca217484051, createdName=huanbaofeng, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=)]
    2018-09-19 jklm09
  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587534, encodeId=8ce6158e53408, content=<a href='/topic/show?id=d1201843d5' target=_blank style='color:#2F92EE;'>#ACE抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1843, encryptionId=d1201843d5, topicName=ACE抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca217484051, createdName=huanbaofeng, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=)]
  6. 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  7. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587534, encodeId=8ce6158e53408, content=<a href='/topic/show?id=d1201843d5' target=_blank style='color:#2F92EE;'>#ACE抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1843, encryptionId=d1201843d5, topicName=ACE抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca217484051, createdName=huanbaofeng, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=)]
  8. 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href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466053, encodeId=88cd146605354, content=<a href='/topic/show?id=217c292009' target=_blank style='color:#2F92EE;'>#ATA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2920, encryptionId=217c292009, topicName=ATA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=387a6772119, createdName=bbjsj_1981, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587534, encodeId=8ce6158e53408, content=<a href='/topic/show?id=d1201843d5' target=_blank style='color:#2F92EE;'>#ACE抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1843, encryptionId=d1201843d5, topicName=ACE抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca217484051, createdName=huanbaofeng, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=)]
    2018-05-22 lqvr
  9. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587534, encodeId=8ce6158e53408, content=<a href='/topic/show?id=d1201843d5' target=_blank style='color:#2F92EE;'>#ACE抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1843, encryptionId=d1201843d5, topicName=ACE抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca217484051, createdName=huanbaofeng, createdTime=Tue May 22 02:50:00 CST 2018, time=2018-05-22, status=1, ipAttribution=)]
    2018-05-22 bbjsj_1981
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