{"id":2989,"date":"2021-04-22T01:29:22","date_gmt":"2021-04-22T01:29:22","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=2989"},"modified":"2023-08-29T17:49:13","modified_gmt":"2023-08-29T17:49:13","slug":"invex-therapeutics-fda-meeting-phase-iii-trial-presendin-treatment-idiopathic-intracranial-hypertension","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=2989","title":{"rendered":"Invex Therapeutics\u5728FDA\u4f1a\u8bae\u4e0a\u6279\u51c6\u63a8\u8fdbPresendin III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7528\u4e8e\u7279\u53d1\u6027\u9885\u5185\u9ad8\u538b\u7684\u6cbb\u7597"},"content":{"rendered":"<p><a href=\"http:\/\/smallcaps-production.test\/stocks\/?symbol=IXC&amp;lang=cn\">Invex Therapeutics (ASX: IXC)<\/a>\u65e5\u524d\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u4e3e\u884c\u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u4e3b\u5bfc\u836f\u7269Presendin\u7528\u4e8e\u6cbb\u7597\u9885\u5185\u538b\u5347\u9ad8\u76f8\u5173\u75be\u75c5\u7684\u8ba1\u5212\u5f00\u53d1\u8def\u5f84\u3002<\/p>\n<p>\u8be5\u516c\u53f8\u5c06\u4e0eFDA\u795e\u7ecf\u5185\u79d1\u90e8\u95e8\u4f1a\u9762\uff0c\u5c31\u8ba1\u5212\u4e2d\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u5bfb\u6c42\u6307\u5bfc\uff0c\u8be5\u4e34\u5e8a\u8bd5\u9a8c\u65e8\u5728\u7814\u7a76\u4f7f\u7528Presendin\u6cbb\u7597\u7279\u53d1\u6027\u9885\u5185\u9ad8\u538b(IIH)\u7b49\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\uff0c\u8fd9\u4e9b\u75be\u75c5\u6ca1\u6709\u5df2\u77e5\u7684\u539f\u56e0\uff0c\u5176\u75c7\u72b6\u53ef\u80fd\u4e0e\u8111\u80bf\u7624\u76f8\u4f3c\u3002<\/p>\n<p>\u8be5\u8ba1\u5212\u5c06\u5305\u62ec\u62df\u8bae\u7684\u4e34\u5e8a\u7ec8\u70b9\u548c\u8be5\u8bd5\u9a8c\u7684\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\uff0c\u9884\u8ba1\u5c06\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u6fb3\u5927\u5229\u4e9a\u8fdb\u884c\u3002<\/p>\n<p>Invex\u7684\u4f1a\u8bae\u88ab\u6807\u8bb0\u4e3a\u201cC\u7c7b\u201d\u4f1a\u8bae\uff0c\u53ea\u8981\u6c42\u5bf9\u4e4b\u524d\u4f5c\u4e3a\u516c\u53f8\u4f1a\u8bae<a href=\"http:\/\/smallcaps-production.test\/invex-therapeutics-pre-ind-meeting-us-fda-presendin-trial-iih-sufferers\/?lang=cn\">\u7533\u8bf7\u7684\u4e00\u90e8\u5206\u63d0\u4ea4\u7684\u7814\u7a76\u65b9\u6848<\/a>\u548c\u8ba1\u5212\u95ee\u9898\u4f5c\u51fa\u4e66\u9762\u7b54\u590d\u3002<\/p>\n<h2>\u53d1\u5c55\u9014\u5f84<\/h2>\n<p>\u4e3b\u5e2dDr Jason Loveridge\u8bf4\uff0c\u7f8e\u56fdFDA\u4f1a\u8bae\u5c06\u6709\u52a9\u4e8e\u63a8\u8fdbPresendin\u7684\u5f00\u53d1\u9014\u5f84\u3002<\/p>\n<p>\u4ed6\u8bf4:\u201c\u76ee\u524d\uff0cIIH\u60a3\u8005\u65e0\u6cd5\u4f9d\u9760\u4efb\u4f55\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u7684\u6cbb\u7597\u836f\u7269\u6765\u7ba1\u7406\u9ad8\u9885\u5185\u538b\uff0c\u5e76\u901a\u8fc7\u79ef\u6781\u5f71\u54cd\u91cd\u8981\u7684\u4e34\u5e8a\u7ed3\u679c(\u5982\u51cf\u5c11\u5934\u75db)\u6765\u6539\u5584\u4ed6\u4eec\u7684\u751f\u6d3b\u8d28\u91cf\u3002\u201d<\/p>\n<p>\u201c\u968f\u7740\u6211\u4eec\u5728\u8fd9\u4e00\u91cd\u8981\u5e02\u573a\u7684\u53d1\u5c55\uff0c\u795e\u7ecf\u75c5\u5b66\u90e8\u95e8\u7684\u6295\u5165\u5c06\u63d0\u4f9b\u6709\u4ef7\u503c\u7684\u53cd\u9988\uff0c\u76ee\u524dIIH\u60a3\u8005\u7684\u6cbb\u7597\u9009\u62e9\u6709\u9650\u3002\u201d<\/p>\n<h2>\u5173\u4e8e\u75be\u75c5\u72b6\u51b5<\/h2>\n<p>\u5f53\u5b58\u5728\u4e8e\u5927\u8111\u548c\u810a\u9ad3\u5468\u56f4\u7684\u8111\u810a\u6db2\u5728\u9885\u9aa8\u5185\u79ef\u805a\u65f6\uff0c\u8111\u810a\u6db2\u538b\u529b\u589e\u52a0\uff0c\u5e76\u5f15\u8d77\u89c6\u529b\u53d8\u5316(\u7531\u4e8e\u89c6\u795e\u7ecf\u53d7\u5230\u538b\u8feb)\u548c\u5934\u75db\u7b49\u75c7\u72b6\uff0c\u5373\u8111\u810a\u6db2\u6027\u8111\u51fa\u8840\u3002<\/p>\n<p>\u8fd9\u79cd\u60c5\u51b5\u5728\u80a5\u80d6\u7684\u80b2\u9f84\u5987\u5973\u4e2d\u6700\u5e38\u89c1\uff0c\u662f\u4e00\u79cd\u5feb\u901f\u589e\u957f\u7684\u5b64\u513f\u9002\u5e94\u75c7\uff0c\u60a3\u8005\u6570\u91cf\u5728\u8fc7\u53bb10\u5e74\u4e2d\u589e\u52a0\u4e86350%\u4ee5\u4e0a\u3002<\/p>\n<h2>\u518d\u5229\u7528Exenatide<\/h2>\n<p>Invex\u76ee\u524d\u4e13\u6ce8\u4e8e\u5c06<a href=\"http:\/\/smallcaps-production.test\/invex-therapeutics-phase-three-trial-repurpose-drug-brain-disorder\/?lang=cn\">\u5df2\u83b7\u6279\u51c6\u7684\u836f\u7269Exenatide<\/a>(\u5546\u6807\u540dPresendin),\u91cd\u65b0\u7528\u4e8e\u6cbb\u7597\u7531\u9885\u5185\u538b\u5347\u9ad8\u5f15\u8d77\u7684\u6216\u6d89\u53ca\u9885\u5185\u538b\u5347\u9ad8\u7684\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\uff0c\u5982IIH\u3001\u6025\u6027\u4e2d\u98ce\u548c\u521b\u4f24\u6027\u8111\u635f\u4f24\u3002<\/p>\n<p>Exenatide\u4e8e2000\u5e74\u4e2d\u671f\u83b7\u5f97\u7f8e\u56fd\u548c\u6b27\u76df\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u75972\u578b\u7cd6\u5c3f\u75c5\u3002<\/p>\n<p>\u53bb\u5e745\u6708\uff0c\u4e00\u9879II\u671f\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6d89\u53caIIH\u60a3\u8005\uff0c\u663e\u793aExenatide\u7ec4\u7684\u5173\u952e\u7ec8\u70b9\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u964d\u4f4e\uff0c\u5305\u62ec\u6240\u6709\u4e0e\u9885\u5185\u538b\u76f8\u5173\u7684\u6307\u6807\u3002<\/p>\n<p>Loveridge\u535a\u58eb\u8bf4\uff0c\u6839\u636e\u5b64\u513f\u836f\u7684\u540d\u79f0\uff0c\u8fd9\u4e9b\u6570\u636e\u652f\u6301\u4e86Presendin\u8fdb\u5165III\u671f\u8bd5\u9a8c\u7684\u8fdb\u5c55\u3002<\/p>\n<h2>\u8d22\u52a1\u4e1a\u7ee9<\/h2>\n<p>Invex\u7b2c\u4e09\u5b63\u5ea6\u8d22\u52a1\u72b6\u51b5\u5f3a\u52b2\uff0c\u73b0\u91d1\u53ca\u73b0\u91d1\u7b49\u4ef7\u7269\u4e3a3,320\u4e07\u6fb3\u5143\u3002<\/p>\n<p>\u8be5\u516c\u53f8\u7684\u5b63\u5ea6\u62a5\u544a\u5f3a\u8c03\u4e8642\u4e07\u6fb3\u5143\u7684\u73b0\u91d1\u6d41\u51fa\uff0c\u5176\u4e2d29\u4e07\u6fb3\u5143\u7528\u4e8e\u7814\u53d1\u652f\u51fa\uff0c\u5176\u4e2d17\u4e07\u6fb3\u5143\u7528\u4e8e\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u76d1\u7ba1\u7533\u62a5\u3002<\/p>\n<h2>\u8463\u4e8b\u7684\u4efb\u547d<\/h2>\n<p>Invex\u8fd8\u5728\u7b2c\u4e09\u5b63\u5ea6<a href=\"http:\/\/smallcaps-production.test\/invex-therapeutics-appoints-biotech-expert-dr-megan-baldwin-board\/?lang=cn\">\u4efb\u547dDr Megan Baldwin<\/a>\u4e3a\u975e\u6267\u884c\u8463\u4e8b\uff0c\u52a0\u5f3a\u4e86\u8463\u4e8b\u4f1a\u7684\u5b9e\u529b\u3002<\/p>\n<p>Dr Baldwin\u662f\u665a\u671f\u751f\u7269\u5236\u836f\u516c\u53f8<a href=\"http:\/\/smallcaps-production.test\/stocks\/?symbol=OPT&amp;lang=cn\">Opthea (ASX: OPT)<\/a>\u7684\u8463\u4e8b\u603b\u7ecf\u7406\uff0c\u8be5\u516c\u53f8\u6b63\u5728\u5f00\u53d1\u4e00\u79cd\u65b0\u7597\u6cd5\uff0c\u4ee5\u89e3\u51b3\u89c6\u7f51\u819c\u773c\u75c5\u6cbb\u7597\u4e2d\u672a\u6ee1\u8db3\u7684\u9700\u6c42\uff0c\u5305\u62ec\u6e7f\u6027\u5e74\u9f84\u76f8\u5173\u6027\u9ec4\u6591\u53d8\u6027(\u6e7f\u6027AMD)\u3002<\/p>\n<p>\u5728Dr Baldwin\u7684\u9886\u5bfc\u4e0b\uff0cOpthea\u773c\u79d1\u9879\u76ee\u901a\u8fc7\u4e86I\u671f\u548cII\u671f\u4e34\u5e8a\u5f00\u53d1\uff0c\u6700\u8fd1\u5b8c\u6210\u4e861.8\u4ebf\u6fb3\u5143\u7684\u9996\u6b21\u516c\u5f00\u52df\u80a1\uff0c\u5e76\u5728\u7f8e\u56fdNASDAQ\u4ea4\u6613\u6240\u4e0a\u5e02\uff0c\u4ee5\u63a8\u8fdb\u6e7f\u6027AMD\u7684\u4e24\u9879\u5173\u952eIII\u671f\u7814\u7a76\u3002<\/p>\n<p>Dr Loveridge\u8bf4:\u201cDr Baldwin\u5728\u836f\u7269\u5f00\u53d1\u3001\u76d1\u7ba1\u53c2\u4e0e\u548c\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u6267\u884c\u65b9\u9762\u7684\u7ecf\u9a8c\u5bf9Invex\u6765\u8bf4\u662f\u65e0\u4ef7\u7684\uff0c\u56e0\u4e3a\u6211\u4eec\u4eca\u5e74\u5c06Presendin\u63a8\u8fdb\u5230\u6211\u4eec\u7684III\u671f\u7814\u7a76\u3002\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Invex Therapeutics (ASX: IXC)\u65e5\u524d\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u4e3e\u884c\u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u4e3b\u5bfc\u836f\u7269Presendin\u7528\u4e8e\u6cbb\u7597\u9885\u5185\u538b\u5347\u9ad8\u76f8\u5173\u75be\u75c5\u7684\u8ba1\u5212\u5f00\u53d1\u8def\u5f84\u3002 \u8be5\u516c\u53f8\u5c06\u4e0eFDA\u795e\u7ecf\u5185\u79d1\u90e8\u95e8\u4f1a\u9762\uff0c\u5c31\u8ba1\u5212\u4e2d\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u5bfb\u6c42\u6307\u5bfc\uff0c\u8be5\u4e34\u5e8a\u8bd5\u9a8c\u65e8\u5728\u7814\u7a76\u4f7f\u7528Presendin\u6cbb\u7597\u7279\u53d1\u6027\u9885\u5185\u9ad8\u538b(IIH)\u7b49\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\uff0c\u8fd9\u4e9b\u75be\u75c5\u6ca1\u6709\u5df2\u77e5\u7684\u539f\u56e0\uff0c\u5176\u75c7\u72b6\u53ef\u80fd\u4e0e\u8111\u80bf\u7624\u76f8\u4f3c\u3002 \u8be5\u8ba1\u5212\u5c06\u5305\u62ec\u62df\u8bae\u7684\u4e34\u5e8a\u7ec8\u70b9\u548c\u8be5\u8bd5\u9a8c\u7684\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\uff0c\u9884\u8ba1\u5c06\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u6fb3\u5927\u5229\u4e9a\u8fdb\u884c\u3002 Invex\u7684\u4f1a\u8bae\u88ab\u6807\u8bb0\u4e3a\u201cC\u7c7b\u201d\u4f1a\u8bae\uff0c\u53ea\u8981\u6c42\u5bf9\u4e4b\u524d\u4f5c\u4e3a\u516c\u53f8\u4f1a\u8bae\u7533\u8bf7\u7684\u4e00\u90e8\u5206\u63d0\u4ea4\u7684\u7814\u7a76\u65b9\u6848\u548c\u8ba1\u5212\u95ee\u9898\u4f5c\u51fa\u4e66\u9762\u7b54\u590d\u3002 \u53d1\u5c55\u9014\u5f84 \u4e3b\u5e2dDr Jason Loveridge\u8bf4\uff0c\u7f8e\u56fdFDA\u4f1a\u8bae\u5c06\u6709\u52a9\u4e8e\u63a8\u8fdbPresendin\u7684\u5f00\u53d1\u9014\u5f84\u3002 \u4ed6\u8bf4:\u201c\u76ee\u524d\uff0cIIH\u60a3\u8005\u65e0\u6cd5\u4f9d\u9760\u4efb\u4f55\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u7684\u6cbb\u7597\u836f\u7269\u6765\u7ba1\u7406\u9ad8\u9885\u5185\u538b\uff0c\u5e76\u901a\u8fc7\u79ef\u6781\u5f71\u54cd\u91cd\u8981\u7684\u4e34\u5e8a\u7ed3\u679c(\u5982\u51cf\u5c11\u5934\u75db)\u6765\u6539\u5584\u4ed6\u4eec\u7684\u751f\u6d3b\u8d28\u91cf\u3002\u201d \u201c\u968f\u7740\u6211\u4eec\u5728\u8fd9\u4e00\u91cd\u8981\u5e02\u573a\u7684\u53d1\u5c55\uff0c\u795e\u7ecf\u75c5\u5b66\u90e8\u95e8\u7684\u6295\u5165\u5c06\u63d0\u4f9b\u6709\u4ef7\u503c\u7684\u53cd\u9988\uff0c\u76ee\u524dIIH\u60a3\u8005\u7684\u6cbb\u7597\u9009\u62e9\u6709\u9650\u3002\u201d \u5173\u4e8e\u75be\u75c5\u72b6\u51b5 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Invex\u76ee\u524d\u4e13\u6ce8\u4e8e\u5c06\u5df2\u83b7\u6279\u51c6\u7684\u836f\u7269Exenatide(\u5546\u6807\u540dPresendin),\u91cd\u65b0\u7528\u4e8e\u6cbb\u7597\u7531\u9885\u5185\u538b\u5347\u9ad8\u5f15\u8d77\u7684\u6216\u6d89\u53ca\u9885\u5185\u538b\u5347\u9ad8\u7684\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\uff0c\u5982IIH\u3001\u6025\u6027\u4e2d\u98ce\u548c\u521b\u4f24\u6027\u8111\u635f\u4f24\u3002 Exenatide\u4e8e2000\u5e74\u4e2d\u671f\u83b7\u5f97\u7f8e\u56fd\u548c\u6b27\u76df\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u75972\u578b\u7cd6\u5c3f\u75c5\u3002 \u53bb\u5e745\u6708\uff0c\u4e00\u9879II\u671f\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6d89\u53caIIH\u60a3\u8005\uff0c\u663e\u793aExenatide\u7ec4\u7684\u5173\u952e\u7ec8\u70b9\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u964d\u4f4e\uff0c\u5305\u62ec\u6240\u6709\u4e0e\u9885\u5185\u538b\u76f8\u5173\u7684\u6307\u6807\u3002 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