Novan报告了SB206针对接触传染性软疣的3期试验疗效结果

2020-01-03 不详 MedSci原创

Novan公司宣布了其缓解一氧化氮释放候选药物SB206用于治疗接触传染性软疣的3期B-SIMPLE计划的疗效。在B-SIMPLE1或B-SIMPLE2中,主要终点均未达到统计显着性,但是在两项研究中,多重敏感性分析均是支持和一致的。两项试验正在进行中,正在等待24周的安全性数据。

Novan公司宣布了其缓解一氧化氮释放候选药物SB206用于治疗接触传染性软疣的3期B-SIMPLE的疗效。在B-SIMPLE1或B-SIMPLE2中,主要终点均未达到统计显着性,但是在两项研究中,多重敏感性分析均是支持和一致的。两项试验正在进行中,正在等待24周的安全性数据。

SB206研究计划摘要:

SB206没有达到主要终点的统计学显着性。

B-SIMPLE2在多项预先指定的敏感性分析中具有统计学意义。

使用B-SIMPLE1进行的类似分析表明,该结果在一定程度上是一致的,并支持B-SIMPLE2。

公司打算将B-SIMPLE2用作提交新药申请("NDA")的确证试验之一,但要与美国食品和药物管理局进行讨论。

公司打算通过开展额外的验证性3期试验(计划于2020年4月开始)来支持B-SIMPLE2,但要获得更多资金和FDA的反馈。

两项试验的全部功效和安全性数据,包括直至第24周的前瞻性计划安全性评估,计划于2020年3月提供。

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    2020-05-19 xzw113
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  3. [GetPortalCommentsPageByObjectIdResponse(id=1911506, encodeId=58e8191150697, content=<a href='/topic/show?id=77b3259009f' target=_blank style='color:#2F92EE;'>#传染性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25900, encryptionId=77b3259009f, topicName=传染性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2317301, createdName=xzw113, createdTime=Tue May 19 15:16:00 CST 2020, time=2020-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1531317, encodeId=d235153131e59, content=<a href='/topic/show?id=4683129675' target=_blank style='color:#2F92EE;'>#3期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1296, encryptionId=4683129675, topicName=3期试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06eb12252541, createdName=zexyw05, createdTime=Sun Jan 05 06:16:00 CST 2020, time=2020-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032374, encodeId=f22b10323e4ee, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Fri Jan 03 18:16:00 CST 2020, time=2020-01-03, status=1, ipAttribution=)]
    2020-01-03 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0