{"id":6767,"date":"2023-10-17T10:04:13","date_gmt":"2023-10-17T14:04:13","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=6767"},"modified":"2023-10-17T10:04:14","modified_gmt":"2023-10-17T14:04:14","slug":"roches-fenebrutinib-breakthrough-in-multiple-sclerosis-treatment-and-blood-brain-barrier-penetration","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/roches-fenebrutinib-breakthrough-in-multiple-sclerosis-treatment-and-blood-brain-barrier-penetration\/","title":{"rendered":"Roche&#8217;s Fenebrutinib Breakthrough in Multiple Sclerosis Treatment and Blood-Brain Barrier Penetration"},"content":{"rendered":"\n<p>In a phase 2 study focused on multiple sclerosis (MS), Roche&#8217;s BTK inhibitor, Fenebrutinib, appears to have achieved a remarkable feat by successfully crossing the blood-brain barrier. Roche recently unveiled a major milestone in the development of its MS drug during the phase 2 FENopta study, indicating its potential as a groundbreaking treatment for the disease.<\/p>\n\n\n\n<p>During the ECTRIMS-ACTRIMS meeting in Milan, Roche presented the results of the FENopta study, which involved 109 adults with relapsing MS. Fenebrutinib, a BTK inhibitor, demonstrated highly promising outcomes. Notably, it displayed a 90% reduction in new or enlarging gadolinium-enhancing T1 lesions, a crucial measure assessed via MRI scans at the 12-week mark, successfully meeting the primary endpoint of the trial. Moreover, the drug exhibited a remarkable 95% reduction in T2 lesions, a secondary endpoint, during the same period. Patients treated with Fenebrutinib were four times more likely to remain free from any new T1 Gd+ brain lesions or T2 brain lesions at weeks 4, 8, and 12 compared to those who received a placebo.<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>One standout achievement highlighted by Roche was Fenebrutinib&#8217;s ability to penetrate the blood-brain barrier, an extraordinary accomplishment in drug development. Roche measured the drug&#8217;s concentration in the cerebrospinal fluid of a subgroup of 11 patients, revealing a mean Fenebrutinib concentration of 43.1 ng\/mL. This suggests that Fenebrutinib can reach levels within the brain and central nervous system that are sufficient to reduce disease activity and progression in MS patients.<\/p>\n\n\n\n<p>Dr. Alexandra Goodyear, Roche&#8217;s global development lead for Fenebrutinib explained that affecting cells in the periphery have shown a profound impact on MS disease activity, and Fenebrutinib&#8217;s dual mechanism of action, targeting both B cells and myeloid cells, holds the potential to impact resident B cells within the central nervous system and microglia if it can penetrate the brain.<\/p>\n\n\n\n<p>While previous trials involving BTK inhibitors have encountered challenges related to serious adverse events, Roche&#8217;s trial reported a consistent safety profile. The rate of adverse events for patients taking Fenebrutinib was 38%, compared to 33% for those on a placebo. Notably, the most common adverse event not observed in the placebo group was abnormal liver enzyme levels, affecting 5.5% of patients receiving Fenebrutinib.<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>Unlike competing candidates, Fenebrutinib is a non-covalent BTK molecule intentionally designed to prioritize long-term safety for patients. Nevertheless, further insights into safety will emerge from ongoing phase 3 trials. Roche is currently conducting two phase 3 studies in relapsing MS and a late-stage study in primary progressive MS, where Fenebrutinib will be compared to the renowned MS drug Ocrevus. However, significant data from these late-stage trials will not be available until later, suggesting a longer timeline for their results to become known.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In a phase 2 study focused on multiple sclerosis (MS), Roche&#8217;s BTK inhibitor, Fenebrutinib, appears to have achieved a remarkable feat by successfully crossing the blood-brain barrier. Roche recently unveiled a major milestone in the development of its MS drug during the phase 2 FENopta study, indicating its potential as a groundbreaking treatment for the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6768,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"class_list":{"0":"post-6767","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6767","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=6767"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6767\/revisions"}],"predecessor-version":[{"id":6769,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6767\/revisions\/6769"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/6768"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=6767"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=6767"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=6767"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}