鞘氨醇激酶2抑制剂Opaganib治疗COVID-19:II/III期研究已在墨西哥获得批准

2020-08-12 Allan MedSci原创

Opaganib是一款口服的鞘氨醇激酶2(SK2)选择性抑制剂,具有抗癌、抗炎和抗病毒活性,针对多种肿瘤、病毒、炎性和胃肠道适应症。

生物制药公司RedHill今日宣布,已获得墨西哥联邦卫生风险保护委员会(COFEPRIS)的批准,以开展Opaganib(Yeliva®,ABC294640)治疗重症SARS-CoV-2感染患者的II/III期临床试验。RedHill的研究现已在墨西哥、英国和俄罗斯获得批准,并且正在意大利、巴西和其他国家/地区进行审查,计划将研究进一步扩展到其他国家。

RedHill的首席运营官Raday说:“随着感染的激增,带来了新的严重病例,药物开发者必须通过严格设计和快速实施的研究来应对。Opaganib是目前正在测试用于治疗重症COVID-19的新型疗法之一”。

这项多中心、随机、双盲、平行臂、安慰剂对照的II/III期研究(NCT04467840)旨在招募多达270名需要住院治疗和补充氧气的重症COVID-19肺炎患者。受试者将以1:1的比例随机分配,以接受opaganib或安慰剂,以及护理标准疗法。该研究的主要终点是在第14天之前评估需要插管和机械通气的患者比例。

同时,opaganib的美国II期临床研究的注册已完成约50%,预计将于本月完成。这项随机、双盲、安慰剂对照研究(NCT04414618)旨在招募多达40例需要住院治疗和补充氧气的重症COVID-19肺炎患者。

Opaganib是一款口服的鞘氨醇激酶2(SK2)选择性抑制剂,具有抗癌、抗炎和抗病毒活性,针对多种肿瘤、病毒、炎性和胃肠道适应症。通过抑制SK2,Opaganib影响与癌症生长、病毒复制和病理性炎症相关的多种细胞途径。Opaganib最初是由Apogee Biotechnology开发,已完成了多项临床前研究和I期临床研究,涉及肿瘤学和炎症。

先前,Opaganib从美国FDA获得了用于治疗胆管癌的孤儿药资格,并且正在评估治疗晚期胆管癌和前列腺癌的有效性。

 

原始出处:

https://www.firstwordpharma.com/node/1748574?tsid=4

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    2020-08-19 juliusluan78
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    2020-11-29 vera_1203
  4. 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  5. 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time=2021-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811416, encodeId=3ccf18114169a, content=<a href='/topic/show?id=26ae8803219' target=_blank style='color:#2F92EE;'>#获得批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Jan 05 12:47:05 CST 2021, time=2021-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1496090, encodeId=7f07149609046, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Fri Aug 14 10:47:05 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594787, encodeId=072e1594e8797, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 14 10:47:05 CST 2020, time=2020-08-14, status=1, ipAttribution=)]
    2020-09-04 jklm09
  6. [GetPortalCommentsPageByObjectIdResponse(id=1916321, encodeId=8cc71916321c0, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Aug 19 07:47:05 CST 2020, time=2020-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021372, encodeId=c44120213e2b2, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, 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time=2021-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811416, encodeId=3ccf18114169a, content=<a href='/topic/show?id=26ae8803219' target=_blank style='color:#2F92EE;'>#获得批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88032, encryptionId=26ae8803219, topicName=获得批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=838d2500169, createdName=12498cb5m13暂无昵称, createdTime=Tue Jan 05 12:47:05 CST 2021, time=2021-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1496090, encodeId=7f07149609046, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Fri Aug 14 10:47:05 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594787, encodeId=072e1594e8797, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 14 10:47:05 CST 2020, time=2020-08-14, status=1, ipAttribution=)]
    2020-09-08 drj2003
  7. 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  8. 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    2020-08-14 redcrab
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8月8日全球新冠肺炎(COVID-19)疫情简报,确诊超1952万,6种疫苗进入三期临床试验,中国占3个

据Worldometers实时统计数据显示,截至北京时间8月8日08时40分,全球新冠肺炎(COVID-19)确诊病例达1952万例,新增273,744至19,523,267例,死亡病例达72万例,新

美国国立卫生研究院(NIH)正在进行COVID-19预防性单克隆抗体的临床试验

目前,两项在健康成年人中进行的安慰剂对照双盲临床试验正在评估实验性单克隆抗体(mAb)是否可以预防SARS-CoV-2冠状病毒感染。

新冠并没有造成更多人死亡——大数据看疫情

随着疫情发展,各方数据涌现。

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Biomedicines:2型糖尿病住院患者COVID-19的长期预后

在T2D合并COVID-19患者中,随访观察到住院死亡率、卒中和心血管住院率增加。

Cureus:2型糖尿病状态、糖尿病并发症严重程度指数评分及其与COVID-19严重程度的关系

与非糖尿病患者相比,我们样本中的糖尿病患者发生COVID-19不良临床结果和住院死亡率的几率更高。

Lancet Infect Dis:口服VV116用于治疗轻中度COVID-19成人患者的有效性和安全性评价

目前,治疗COVID-19的医疗需求仍未得到满足,新型抗病毒药物-VV116可用于治疗轻中度COVID-19成人患者,能够显著缩短临床症状持续时间,与其他药物较少发生药物间相互作用,且安全性良好。

论文解读|Yihua Wang教授团队新研究揭示了揭示COVID-19对肺癌治疗和研究的深远影响

该文章揭示了此次大流行对肺癌治疗、临床试验、研究活动的影响。

JAMA Intern Med:COVID-19相关急性肾损伤与长期肾脏结果

与患有其他疾病相关AKI的患者相比,COVID-AKI住院幸存者的MAKE发生率、长期肾功能下降和死亡率均显著较低。

【解读分享】2024 PIDS共识声明:儿童和青少年COVID-19预防和管理指南

本文主要针对儿童和青少年COVID-19预防和管理提供指导建议,涉及COVID-19的危险分层、治疗和预防,点击即可下载查看。