{"id":395234,"date":"2020-12-08T08:03:46","date_gmt":"2020-12-08T13:03:46","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=395234"},"modified":"2020-12-08T08:03:46","modified_gmt":"2020-12-08T13:03:46","slug":"ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm\/","title":{"rendered":"iX Biopharma receives positive EMA Scientific Advice for Wafermine(TM)"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>EMA has endorsed iX Biopharma&#8217;s proposed Phase 3 clinical development programme for Wafermine\u2122 <\/li>\n<li>EMA Scientific Advice provides clarity on registration pathway in <span class=\"xn-location\">Europe<\/span><\/li>\n<\/ul>\n<p>\n        <span class=\"xn-location\">SINGAPORE<\/span>, Dec. 8,\u00a02020 \/PRNewswire\/ &#8212; Specialty pharmaceutical company <b>iX Biopharma Ltd<\/b> (SGX:42C) (&#8220;iX Biopharma&#8221; or, &#8220;the Company&#8221;) is pleased to announce that it has received positive feedback from the European Medicines Agency (EMA) in its scientific advice to the Company regarding its Phase 3 clinical development programme for Wafermine\u2122, its sublingual ketamine wafer, for registration in <span class=\"xn-location\">Europe<\/span> (the &#8220;EMA Scientific Advice&#8221;).<\/p>\n<p>In the EMA Scientific Advice, the EMA endorsed the Company&#8217;s proposed design of the pivotal Phase 3 studies. The Phase 3 programme, which has been similarly agreed by the US FDA, consists of two randomised, double blind, placebo controlled studies, one in an orthopaedic pain model (bunionectomy) and one in a soft-tissue pain model (abdominoplasty). The primary efficacy measure for both studies will be SPID12, which is the summed pain intensity difference over 12 hours. The summed pain intensity difference over 24 hours (SPID24) and 48 hours (SPID48) will be evaluated as secondary endpoints. The Phase 3 studies will use the same pain models and primary endpoint that was successfully evaluated in Wafermine\u2122&#8217;s Phase <span class=\"xn-money\">2b<\/span> clinical study.<\/p>\n<p>With the successful outcome of the EMA Scientific Advice and End-of-Phase 2 meeting with the US FDA, the Company has now reached consensus with the regulators of the major markets of <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">the United States<\/span> on the remaining clinical development required to support the approval of Wafermine\u2122\u00a0for the treatment of acute moderate to severe pain in those markets.<\/p>\n<p>\n        <b>Dr. Janakan Krishnarajah, Chief Operating Officer and Chief Medical Officer of iX Biopharma said: <\/b><br \/>\n        <i>&#8220;EMA&#8217;s endorsement of the proposed Phase 3 programme design is an exciting achievement that affirms the robustness of our clinical development approach. The EMA response confirms that our development strategy will satisfy the clinical study requirements for both US and European approval, and provides clarity to programme cost and timelines. This makes Wafermine<\/i>\u2122<i>\u00a0a very attractive late stage partnering opportunity for both US and European markets.<\/i>&#8220;<\/p>\n<p>For more information on Wafermine\u2122, please refer to the link below:<br \/>[<a target=\"_blank\" href=\"https:\/\/www.ixbiopharma.com\/wafermine\" rel=\"nofollow noopener noreferrer\">https:\/\/www.ixbiopharma.com\/wafermine<\/a>]<\/p>\n<p>\n        <b>About iX Biopharma Ltd<\/b>\n      <\/p>\n<p>iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in <span class=\"xn-location\">Australia<\/span>. The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.<\/p>\n<p>\n        <b>Contact for media<\/b><br \/>\n        <b>:<\/b>\n      <\/p>\n<p>\n        <b>Dr Janakan Krishnarajah<br \/><\/b>Chief Operating Officer and Chief Medical Officer<br \/>T: +65 6235 2270<br \/>E: <a target=\"_blank\" href=\"mailto:j.krishnarajah@ixbiopharma.com\" rel=\"nofollow noopener noreferrer\">j.krishnarajah@ixbiopharma.com<\/a><\/p>\n<p>\n        <b>Investor Relations:<br \/><span class=\"xn-person\">Eva Tan<\/span><br \/><\/b>Director, Corporate and Commercial Strategy<br \/>T: +65 6235 3212<br \/>E: <a target=\"_blank\" href=\"mailto:eva.tan@ixbiopharma.com\" rel=\"nofollow noopener noreferrer\">eva.tan@ixbiopharma.com<\/a><\/p>\n<p>\n        <b><br \/>\n          <span class=\"xn-person\">Kamal Samuel<\/span>\/Ngo Yit Sung\/<span class=\"xn-person\">Jonathan Wee<\/span><br \/><\/b>T: +65 6438 2990<br \/>E: <a target=\"_blank\" href=\"mailto:Tech@financialpr.com.sg\" rel=\"nofollow noopener noreferrer\">Tech@financialpr.com.sg<\/a><\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=HK16484&amp;sd=2020-12-08\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm-301187988.html\">http:\/\/www.prnewswire.com\/news-releases\/ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm-301187988.html<\/a><\/p>\n<p>SOURCE  iX Biopharma Ltd<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=HK16484&amp;Transmission_Id=202012080800PR_NEWS_USPR_____HK16484&amp;DateId=20201208\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire EMA has endorsed iX Biopharma&#8217;s proposed Phase 3 clinical development programme for Wafermine\u2122 EMA Scientific Advice provides clarity on registration pathway in Europe SINGAPORE, Dec. 8,\u00a02020 \/PRNewswire\/ &#8212; Specialty pharmaceutical company iX Biopharma Ltd (SGX:42C) (&#8220;iX Biopharma&#8221; or, &#8220;the Company&#8221;) is pleased to announce that it has received positive feedback from the European Medicines Agency (EMA) in its scientific advice to the Company regarding its Phase 3 clinical development programme for Wafermine\u2122, its sublingual ketamine wafer, for registration in Europe (the &#8220;EMA Scientific Advice&#8221;). In the EMA Scientific Advice, the EMA endorsed the Company&#8217;s proposed design of the pivotal Phase 3 studies. The Phase 3 programme, which has been similarly agreed by the US FDA, consists of two &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;iX Biopharma receives positive EMA Scientific Advice for Wafermine(TM)&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-395234","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>iX Biopharma receives positive EMA Scientific Advice for Wafermine(TM) - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ix-biopharma-receives-positive-ema-scientific-advice-for-waferminetm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"iX Biopharma receives positive EMA Scientific Advice for Wafermine(TM) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire EMA has endorsed iX Biopharma&#8217;s proposed Phase 3 clinical development programme for Wafermine\u2122 EMA Scientific Advice provides clarity on registration pathway in Europe SINGAPORE, Dec. 8,\u00a02020 \/PRNewswire\/ &#8212; Specialty pharmaceutical company iX Biopharma Ltd (SGX:42C) (&#8220;iX Biopharma&#8221; or, &#8220;the Company&#8221;) is pleased to announce that it has received positive feedback from the European Medicines Agency (EMA) in its scientific advice to the Company regarding its Phase 3 clinical development programme for Wafermine\u2122, its sublingual ketamine wafer, for registration in Europe (the &#8220;EMA Scientific Advice&#8221;). In the EMA Scientific Advice, the EMA endorsed the Company&#8217;s proposed design of the pivotal Phase 3 studies. 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In the EMA Scientific Advice, the EMA endorsed the Company&#8217;s proposed design of the pivotal Phase 3 studies. 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