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壮士断腕 吉利德新药selonsertib舍弃PAH、DKD专注NASH领域研发

2016-10-24 佚名 生物谷

吉利德新药
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制药巨头吉利德公司最近公布了一个喜忧参半的结果。公司开发的新药GS-4997 (selonsertib)在治疗肺动脉高压（PAH）和糖尿病性肾病（DKD）两项临床II期研究中双双未能达到其临床终点。公司在详细分析此次数据后，最终决定放弃GS-4997 在上述两种疾病领域中的开发工作。不过，不幸中的万幸则是，GS-4997 在治疗NASH的临床II期研究中展现出了曙光。 GS-4997 是一

制药巨头吉利德公司最近公布了一个喜忧参半的结果。公司开发的新药GS-4997 (selonsertib)在治疗肺动脉高压（PAH）和糖尿病性肾病（DKD）两项临床II期研究中双双未能达到其临床终点。公司在详细分析此次数据后，最终决定放弃GS-4997 在上述两种疾病领域中的开发工作。不过，不幸中的万幸则是，GS-4997 在治疗NASH的临床II期研究中展现出了曙光。

GS-4997 是一种靶向细胞凋亡信号调节激酶-1的抑制剂药物。在一项治疗NASH的非盲临床II期研究中，研究人员发现这一药物有助于防止患者肝部纤维化。这一研究中招募了72名患有NASH的患者，这些患者肝脏分别出现了中度甚至重度肝纤维化。研究人员对比了每天口服GS-4997 18mg剂量组和6mg剂量组的疗效以及上述剂量组与吉利德另一药物 simtuzumab (SIM)联合治疗或单独服用SIM的疗效。经过24周的治疗后，联合治疗18mg剂量组30名患者中有13名患者肝纤维化程度显着降低（重度转为中度或中度转为轻度），6mg联合治疗组27名患者中有8名患者出现同样疗效。而接受SIM治疗的10名患者中仅有2名有效。

这一结果不仅让公司看到了GS-4997 未来发展方向所在，同时还让SIM的前景变得明朗。此前SIM在治疗肿瘤以及特发性肺纤维化的临床研究中先后失利。今后，公司或将其研究重点转向NASH领域。

公司预计下月公布此次临床研究的具体细节。近年来围绕NASH疗法领域，众多制药巨头展开了龙争虎斗。面对NASH高达400亿美元的市场份额，吉利德自然不能放过这个机会。此次GS-4997 的研究数据无疑将会成为刺激该领域疗法研发竞争进一步加剧的导火索。不过，吉利德是否能像在丙肝药物市场中那样赢得干净利索，还需要时间来检验。

原始出处

Gilead drops PAH, DKD tests after PhII failure; highlights positive noises for NASH


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  1. [GetPortalCommentsPageByObjectIdResponse(id=2007717, encodeId=84bc200e7176d, content=<a href='/topic/show?id=806c16119b4' target=_blank style='color:#2F92EE;'>#Selonsertib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16119, encryptionId=806c16119b4, topicName=Selonsertib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Sat Sep 16 04:00:00 CST 2017, time=2017-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299959, encodeId=310a129995933, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301172, encodeId=d6f513011e2eb, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460190, encodeId=050614601909f, content=<a href='/topic/show?id=1519136e641' target=_blank style='color:#2F92EE;'>#PAH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13676, encryptionId=1519136e641, topicName=PAH)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87966261195, createdName=hb2010ye, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545513, encodeId=dc201545513a1, content=<a href='/topic/show?id=aa77602136' target=_blank style='color:#2F92EE;'>#DKD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6021, encryptionId=aa77602136, topicName=DKD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=773213763478, createdName=12498b08m94暂无昵称, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2017-09-16 snowpeakxu

    #Selonsertib#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2007717, encodeId=84bc200e7176d, content=<a href='/topic/show?id=806c16119b4' target=_blank style='color:#2F92EE;'>#Selonsertib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16119, encryptionId=806c16119b4, topicName=Selonsertib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Sat Sep 16 04:00:00 CST 2017, time=2017-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299959, encodeId=310a129995933, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301172, encodeId=d6f513011e2eb, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460190, encodeId=050614601909f, content=<a href='/topic/show?id=1519136e641' target=_blank style='color:#2F92EE;'>#PAH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13676, encryptionId=1519136e641, topicName=PAH)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87966261195, createdName=hb2010ye, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545513, encodeId=dc201545513a1, content=<a href='/topic/show?id=aa77602136' target=_blank style='color:#2F92EE;'>#DKD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6021, encryptionId=aa77602136, topicName=DKD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=773213763478, createdName=12498b08m94暂无昵称, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2016-10-26 lqvr

    #研发#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2007717, encodeId=84bc200e7176d, content=<a href='/topic/show?id=806c16119b4' target=_blank style='color:#2F92EE;'>#Selonsertib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16119, encryptionId=806c16119b4, topicName=Selonsertib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Sat Sep 16 04:00:00 CST 2017, time=2017-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299959, encodeId=310a129995933, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301172, encodeId=d6f513011e2eb, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460190, encodeId=050614601909f, content=<a href='/topic/show?id=1519136e641' target=_blank style='color:#2F92EE;'>#PAH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13676, encryptionId=1519136e641, topicName=PAH)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87966261195, createdName=hb2010ye, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545513, encodeId=dc201545513a1, content=<a href='/topic/show?id=aa77602136' target=_blank style='color:#2F92EE;'>#DKD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6021, encryptionId=aa77602136, topicName=DKD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=773213763478, createdName=12498b08m94暂无昵称, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2016-10-26 kksonne

    #ASH#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2007717, encodeId=84bc200e7176d, content=<a href='/topic/show?id=806c16119b4' target=_blank style='color:#2F92EE;'>#Selonsertib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16119, encryptionId=806c16119b4, topicName=Selonsertib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Sat Sep 16 04:00:00 CST 2017, time=2017-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299959, encodeId=310a129995933, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301172, encodeId=d6f513011e2eb, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460190, encodeId=050614601909f, content=<a href='/topic/show?id=1519136e641' target=_blank style='color:#2F92EE;'>#PAH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13676, encryptionId=1519136e641, topicName=PAH)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87966261195, createdName=hb2010ye, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545513, encodeId=dc201545513a1, content=<a href='/topic/show?id=aa77602136' target=_blank style='color:#2F92EE;'>#DKD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6021, encryptionId=aa77602136, topicName=DKD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=773213763478, createdName=12498b08m94暂无昵称, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2016-10-26 hb2010ye

    #PAH#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2007717, encodeId=84bc200e7176d, content=<a href='/topic/show?id=806c16119b4' target=_blank style='color:#2F92EE;'>#Selonsertib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16119, encryptionId=806c16119b4, topicName=Selonsertib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Sat Sep 16 04:00:00 CST 2017, time=2017-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1299959, encodeId=310a129995933, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301172, encodeId=d6f513011e2eb, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460190, encodeId=050614601909f, content=<a href='/topic/show?id=1519136e641' target=_blank style='color:#2F92EE;'>#PAH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13676, encryptionId=1519136e641, topicName=PAH)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87966261195, createdName=hb2010ye, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545513, encodeId=dc201545513a1, content=<a href='/topic/show?id=aa77602136' target=_blank style='color:#2F92EE;'>#DKD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6021, encryptionId=aa77602136, topicName=DKD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=773213763478, createdName=12498b08m94暂无昵称, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2016-10-26 12498b08m94暂无昵称

    #DKD#

    0