{"id":8269,"date":"2024-04-10T04:32:37","date_gmt":"2024-04-10T04:32:37","guid":{"rendered":"https:\/\/economicherald.net\/?p=8269"},"modified":"2024-04-10T04:32:37","modified_gmt":"2024-04-10T04:32:37","slug":"pharmaust-inks-approval-from-macquarie-university-for-open-label-mnd-extension-study","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=8269","title":{"rendered":"PharmAust inks approval from Macquarie University for Open-Label MND extension study"},"content":{"rendered":"<p>Macquarie University has given ethics approval to PharmAust allowing the final 3 patients to be enrolled in the Open-Label Extension study of monepantel<br \/>\nThe study started at Calvary Health Care Bethlehem in February and 9 of the 12 eligible patients have enrolled on the study to date<br \/>\nThe Phase 1 MEND study, compassionate-use program, and OLE study have now seen patients treated continuously with monepantel for up to 19 months<\/p>\n<p>\u00a0<\/p>\n<p><strong><em>Special Report:<\/em> Macquarie University has given PharmAust the green light to conduct an Open-Label extension study of monepantel (MPL) in patients with Motor Neurone Disease. <\/strong><\/p>\n<p>The study\u2019s overarching objective is to assess the long-term safety and tolerability of MPL as well as the biomarkers and efficacy endpoints of 12 patients who took part in the Phase 1 MEND study.<\/p>\n<p>Using a daily dose of 10mg\/kg body weight of MPL, the 12-month Open Label Extension (OLE) study will collect ongoing data and further test the hypotheses that MPL administration to individuals living with MND\/ALS will safely reduce disease-associated protein accumulation in motor neurons and provide therapeutic benefits.<\/p>\n<p>The study kicked off at Calvary Health Care Bethlehem in February with 9 of the 12 eligible patients enrolled to date.<\/p>\n<p>Patients have now been treated continuously for up to 19 months without safety concerns. For these 12 patients the average time since diagnosis is now 29.9 months, contrasting with population-based prospective registries which report 1 year mortality rates after diagnosis ranging from 22% to 34%.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>Remaining 3 patients can now benefit from MPL <\/strong><\/h2>\n<p>\u201cWe are delighted and excited to receive ethics approval from Macquarie University, which allows us to offer all Phase 1 MEND patients the opportunity to enrol in the Open-Label Extension study,\u201d PAA CEO Dr Michael Thurn says.<\/p>\n<p><strong>\u00a0\u201c<\/strong>It\u2019s incredibly rewarding to know that 9 patients have already been enrolled at Calvary Health Care Bethlehem and the remaining 3 patients can now continue receiving benefit from treatment with monepantel.\u201d<\/p>\n<p>\u00a0<\/p>\n<h2><strong>A highly significant market opportunity<\/strong><\/h2>\n<p>Motor neurone disease (MND), or amyotrophic lateral sclerosis (ALS), presents a major market opportunity for PharmAust should MPL be approved in major regulatory jurisdictions such as the United States and Europe.<\/p>\n<p>In the US and western Europe it is estimated there are more than 37,000 and 56,000 patients with MND\/ALS, respectively, with more than 268,000 globally.<\/p>\n<p>The MND\/ALS treatment market was more than US$9 billion in 2022 and is estimated to each USD $23 billion by the end of 2035. In 2021, the median treatment cost was US$218,872 for orphan drugs (ranging from US$237 to US$1,272,021).<\/p>\n<p>The last three drugs (Qalsody, Radicava, and Relyvrio) that received US Food and Drug Administration approval for the treatment of MND\/ALS each have an annual cost of between US$150,000 to US$200,000, with Relyvrio having generated US$381m in sales during 2023, its first year after launch.<\/p>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span>\u00a0<\/p>\n<p><em>This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n<p><em>\u00a0<\/em><\/p>\n<p><em>This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n<p><span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/pharmaust-inks-approval-from-macquarie-university-for-open-label-mnd-extension-study\/\">PharmAust inks approval from Macquarie University for Open-Label MND extension study<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Macquarie University has given ethics approval to PharmAust allowing the final 3 patients to be enrolled in the Open-Label Extension study of monepantel The study <a href=\"https:\/\/economicherald.net\/?p=8269\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":8270,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-8269","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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