{"id":496,"date":"2024-09-03T16:13:22","date_gmt":"2024-09-03T08:13:22","guid":{"rendered":"https:\/\/flcube.com\/?p=496"},"modified":"2024-11-23T20:26:51","modified_gmt":"2024-11-23T12:26:51","slug":"sanofis-tolebrutinib-shows-mixed-results-in-phase-iii-multiple-sclerosis-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=496","title":{"rendered":"Sanofi&#8217;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials"},"content":{"rendered":"\n<p>PARIS\u2014French pharmaceutical giant Sanofi (<a href=\"https:\/\/www.google.com\/finance\/quote\/SNY:NASDAQ\">NASDAQ: SNY<\/a>) has reported mixed outcomes from three Phase III trials for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi\u2019s own therapy Aubagio (teriflunomide).<\/p>\n\n\n\n<p>Sanofi, aiming to become the first company to successfully apply a BTK inhibitor to MS treatment, faces a setback with these results. The company had previously licensed orelabrutinib, a BTKi, to Biogen (Nasdaq: BIIB) for MS development in 2021, but Biogen returned the rights to Beijing InnoCare Pharma Tech Co., (09969.HK) last year following safety issues during trials.<\/p>\n\n\n\n<p>The HERCULES study&#8217;s focus on nrSPMS patients, who no longer experience relapses but continue to see worsening disabilities, highlights a currently untreated patient group. Sanofi has indicated that the positive results from this study will be used as a foundation for future discussions with global regulatory authorities regarding tolebrutinib&#8217;s potential application in MS treatment.<\/p>\n\n\n\n<p>With one more Phase III trial ongoing for tolebrutinib in primary progressive MS, expected results in 2025, Sanofi continues to seek breakthroughs in the treatment of this complex disease.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PARIS\u2014French pharmaceutical giant Sanofi (NASDAQ: SNY) has reported mixed outcomes from three Phase III trials&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[17,867,147,33],"class_list":["post-496","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-nasdaq-sny","tag-sanofi","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sanofi&#039;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"PARIS\u2014French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi\u2019s own therapy Aubagio (teriflunomide).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=496\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sanofi&#039;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=496\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-03T08:13:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-23T12:26:51+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Sanofi&#8217;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials\",\"datePublished\":\"2024-09-03T08:13:22+00:00\",\"dateModified\":\"2024-11-23T12:26:51+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496\"},\"wordCount\":258,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Clinical trial results\",\"NASDAQ: SNY\",\"Sanofi\",\"TKIs (EGFR VEGF BTK etc.)\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=496#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=496\",\"name\":\"Sanofi's Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-09-03T08:13:22+00:00\",\"dateModified\":\"2024-11-23T12:26:51+00:00\",\"description\":\"PARIS\u2014French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi\u2019s own therapy Aubagio (teriflunomide).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=496\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=496#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Sanofi&#8217;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Sanofi's Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials - Insight, China&#039;s Pharmaceutical Industry","description":"PARIS\u2014French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi\u2019s own therapy Aubagio (teriflunomide).","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:\/\/flcube.com\/?p=496","og_locale":"en_US","og_type":"article","og_title":"Sanofi's Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=496","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-09-03T08:13:22+00:00","article_modified_time":"2024-11-23T12:26:51+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=496#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=496"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Sanofi&#8217;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials","datePublished":"2024-09-03T08:13:22+00:00","dateModified":"2024-11-23T12:26:51+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=496"},"wordCount":258,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Clinical trial results","NASDAQ: SNY","Sanofi","TKIs (EGFR VEGF BTK etc.)"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=496#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=496","url":"https:\/\/flcube.com\/?p=496","name":"Sanofi's Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-09-03T08:13:22+00:00","dateModified":"2024-11-23T12:26:51+00:00","description":"PARIS\u2014French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton\u2019s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi\u2019s own therapy Aubagio (teriflunomide).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=496#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=496"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=496#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sanofi&#8217;s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/496","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=496"}],"version-history":[{"count":5,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/496\/revisions"}],"predecessor-version":[{"id":14435,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/496\/revisions\/14435"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=496"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}