{"id":384602,"date":"2020-11-18T19:33:25","date_gmt":"2020-11-19T00:33:25","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=384602"},"modified":"2020-11-18T19:33:25","modified_gmt":"2020-11-19T00:33:25","slug":"asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/","title":{"rendered":"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <span id=\"spanHghlt2ecd\">SHANGHAI\u00a0and <span class=\"xn-location\">SAN FRANCISCO<\/span><\/span>, <span id=\"spanHghlt446f\"><span class=\"xn-chron\">Nov. 18, 2020<\/span><\/span> \/PRNewswire\/ &#8212; Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in <span class=\"xn-location\">China<\/span>. The trial in <span class=\"xn-location\">China<\/span> with 30 patients enrolled is part of the global Phase 2 clinical program.<\/p>\n<p>On <span class=\"xn-chron\">June 17<\/span>, Sagimet Biosciences\u00a0Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 <span id=\"spanHghlt050b\">(<\/span>TVB-2640<span id=\"spanHghlt82d9\">) <\/span>from its Phase 2 (FASCINATE-1) clinical trial in <span class=\"xn-location\">the United States<\/span>. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis. In this randomized, placebo-controlled trial of 99 patients in <span class=\"xn-location\">the United States<\/span>, clinicians evaluated the safety and efficacy of ASC40 <span id=\"spanHghlta0d2\">(<\/span>TVB-2640<span id=\"spanHghlt0f6b\">)<\/span> for 12 weeks. ASC40 <span id=\"spanHghlt86ac\">(<\/span>TVB-2640<span id=\"spanHghlt9fc6\">) <\/span>was well-tolerated with a benign adverse event profile, predominantly grade 1 adverse events and no on-treatment serious adverse events. <\/p>\n<p>&#8220;This is the first Phase 2 NASH trial that has completed patient enrollment in mainland <span class=\"xn-location\">China<\/span>, which enables the completion of 12 week treatment of all patients in <span class=\"xn-chron\">February 2021<\/span>,&#8221; said Dr. <span class=\"xn-person\">Junping Shi<\/span>, Deputy Dean of the Affiliated Hospital of Hangzhou Normal University, Deputy Leader of the Fatty Liver and Alcoholic Hepatology Group of the Chinese Medical Association Hepatology Branch, principal investigator of ASC40 (TVB-2640) Phase 2 trial in <span class=\"xn-location\">China<\/span><span id=\"spanHghlt9246\">. &#8220;<\/span>We are excited by results from the Phase 2 NASH trial in <span class=\"xn-location\">the United States<\/span>. Based upon the data from the bridging study in <span class=\"xn-location\">China<\/span>, I believe the efficacy of ASC40 (TVB-2640) in Chinese patients will be similarly potent.&#8221;<\/p>\n<p>&#8220;Additional data from U.S. patients were recently presented by Dr. <span class=\"xn-person\">Rohit Loomba<\/span> at The Liver Meeting of American Association for the Study of Liver Diseases (AASLD) that confirm the potential benefit of TVB-2640 to NASH patients. We are excited to move forward with our planned Phase <span class=\"xn-money\">2b<\/span> biopsy trial, as well as work with our partner Gannex to understand better dosing of TVB-2640 in Chinese patients,&#8221; said <span class=\"xn-person\">George Kemble<\/span>, CEO of Sagimet.<\/p>\n<p>&#8220;We are pleased that we completed the patient enrollment ahead of the schedule and want to thank all patients and doctors. I look forward to the completion of this Phase 2 NASH trial in <span class=\"xn-location\">China<\/span>,&#8221; said Dr. <span class=\"xn-person\">Jinzi J. Wu<\/span>, Founder, Chairman and CEO of Ascletis.<\/p>\n<p>\n        <b>About TVB-2640<\/b>\n      <\/p>\n<p>TVB-2640 is an orally bioavailable, first-in-class FASN inhibitor. FASN is a key enzyme in the de novo lipogenesis (DNL) pathway that is responsible for the synthesis of excess fat and activation of fibrogenic and inflammatory mechanisms in the liver of patients with NASH. Sagimet&#8217;s approach targets these key drivers of NASH. The company announced in <span class=\"xn-chron\">June 2020<\/span> initial results of a randomized, placebo-controlled Phase 2 trial, FASCINATE-1, which evaluated the impact of TVB-2640 in 99 NASH patients in <span class=\"xn-location\">the United States<\/span>. Sagimet and its partner, Gannex Pharma Co., Ltd., have completed the enrollment of 30 NASH patients in <span class=\"xn-location\">China<\/span>. Based upon the strength of this Phase 2 imaging and biomarker data, Sagimet expects to initiate a Phase <span class=\"xn-money\">2b<\/span> biopsy trial in 1H 2021. The company has demonstrated in preclinical models that blocking FASN not only reduces liver fat, but directly reduces fibrosis and inflammation\u2013 addressing three major drivers of NASH.<\/p>\n<p>\n        <b>About Sagimet<\/b>\n      <\/p>\n<p>Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat important diseases such as the liver disease NASH and specific cancers, with focus on targeting dysfunctional metabolic pathways. The company has unique expertise in FASN biology and has created a pipeline of proprietary FASN inhibitors. For more information, please visit <a target=\"_blank\" href=\"http:\/\/www.sagimet.com\/\" rel=\"nofollow noopener noreferrer\">www.sagimet.com<\/a>.<\/p>\n<p>\n        <b>About Ascletis <\/b>\n      <\/p>\n<p>Ascletis is an innovative R&amp;D driven biotech and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs of viral hepatitis, NASH and HIV\/AIDS, for unmet medical needs in <span class=\"xn-location\">China<\/span> and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis has three marketed products and thirteen R&amp;D pipeline drug candidates or combination therapies (nine of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir\u00ae and Ganovo\u00ae combination (RDV\/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV\/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis &#8216; hepatitis C products. (ii) marketed Pegasys\u00ae for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets \u2013 FASN, THR-beta and FXR, and three combination therapies. NASH is a global disease, Ascletis conducts global clinical research in <span class=\"xn-location\">Europe<\/span>, America and <span class=\"xn-location\">China<\/span>. 3. HIV\/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit <a target=\"_blank\" href=\"http:\/\/www.ascletis.com\/\" rel=\"nofollow noopener noreferrer\">www.ascletis.com<\/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=CN97393&amp;sd=2020-11-18\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china-301176538.html\">http:\/\/www.prnewswire.com\/news-releases\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china-301176538.html<\/a><\/p>\n<p>SOURCE  Ascletis Pharma Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CN97393&amp;Transmission_Id=202011181930PR_NEWS_USPR_____CN97393&amp;DateId=20201118\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire SHANGHAI\u00a0and SAN FRANCISCO, Nov. 18, 2020 \/PRNewswire\/ &#8212; Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in China. The trial in China with 30 patients enrolled is part of the global Phase 2 clinical program. On June 17, Sagimet Biosciences\u00a0Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial in the United States. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China&#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-384602","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China - 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\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire SHANGHAI\u00a0and SAN FRANCISCO, Nov. 18, 2020 \/PRNewswire\/ &#8212; Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in China. The trial in China with 30 patients enrolled is part of the global Phase 2 clinical program. On June 17, Sagimet Biosciences\u00a0Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial in the United States. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. &hellip; Continue reading &quot;ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-19T00:33:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN97393&amp;sd=2020-11-18\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China\",\"datePublished\":\"2020-11-19T00:33:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/\"},\"wordCount\":846,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/c212.net\\\/c\\\/img\\\/favicon.png?sn=CN97393&amp;sd=2020-11-18\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\\\/\",\"name\":\"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/","og_locale":"en_US","og_type":"article","og_title":"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China - Market Newsdesk","og_description":"PR Newswire SHANGHAI\u00a0and SAN FRANCISCO, Nov. 18, 2020 \/PRNewswire\/ &#8212; Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in China. The trial in China with 30 patients enrolled is part of the global Phase 2 clinical program. On June 17, Sagimet Biosciences\u00a0Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial in the United States. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. &hellip; Continue reading \"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-19T00:33:25+00:00","og_image":[{"url":"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN97393&amp;sd=2020-11-18","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China","datePublished":"2020-11-19T00:33:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/"},"wordCount":846,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/#primaryimage"},"thumbnailUrl":"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN97393&amp;sd=2020-11-18","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china\/","name":"ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China - 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