{"id":796669,"date":"2024-12-23T07:03:37","date_gmt":"2024-12-23T12:03:37","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\/"},"modified":"2024-12-23T07:03:37","modified_gmt":"2024-12-23T12:03:37","slug":"blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\/","title":{"rendered":"Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>Blarcamesine: Potential novel oral treatment to target upstream Alzheimer\u2019s disease pathology through autophagy enhancement<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Submission based on favorable ANAVEX<sup>\u00ae<\/sup>2-73-AD-004 trial results in patients with early Alzheimer\u2019s disease<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer&#8217;s disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events<\/em>\n      <\/p>\n<p align=\"justify\">NEW YORK, Dec.  23, 2024  (GLOBE NEWSWIRE) &#8212; Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer&#8217;s disease, Parkinson&#8217;s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX<sup>\u00ae<\/sup>2-73), an investigational drug for the treatment of Alzheimer\u2019s disease. The Company is looking forward to working with the EMA.<\/p>\n<p align=\"justify\">Blarcamesine is an orally once daily administered small molecule for the potential treatment of patients with Alzheimer\u2019s disease.<\/p>\n<p align=\"justify\">\u201cThe EMA filing acceptance for blarcamesine to review the Marketing Authorization Application potentially brings us a step closer offering broader patient access to a new treatment option in Europe, and we look forward to continued engagement with the EMA,\u201d said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. \u201cThrough our clinical development program, we have seen that blarcamesine has the potential to slow the progression of this relentless and ultimately fatal disease.\u201d\u00a0<\/p>\n<p align=\"justify\">The MAA is supported by data from the randomized, double-blind, placebo-controlled Phase IIb\/III, ANAVEX<sup>\u00ae<\/sup>2-73-AD-004 trial and it\u2019s up to 144 week open-label-extension (OLE) ATTENTION-AD ANAVEX\u00ae2-73-AD-EP-004 trial investigating blarcamesine in early Alzheimer\u2019s disease. Former study was recently accepted in a peer-reviewed medical journal with focus on Alzheimer\u2019s disease titled, \u201c<em>Blarcamesine for the treatment of Early Alzheimer\u2019s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB\/III trial<\/em>.\u201d<\/p>\n<p align=\"justify\">Strengthening the submission is the 265 week (~5-year) Phase 2a trial investigating blarcamesine in mild-to-moderate Alzheimer\u2019s disease, with interim preliminary data published in the peer-reviewed medical journal, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=m5ddh4Z5mUQdl_2oKXm7nS0Ji3eGoDGlverV05TiEEhBM8cPfyL2ABoDWNS8iph4t0yhSynEtsdJwcMtlQWynTQ5YruwINI4DiEbNEJw-jvWavv4hD8N0cwYUSJn991h\" rel=\"nofollow\" target=\"_blank\">Alzheimer\u2019s &amp; Dementia<\/a>, titled: \u201c<em>A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer&#8217;s disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study.<\/em>\u201d<\/p>\n<p align=\"justify\">\u201cWe look forward to working with the EMA and thank the team at Anavex for their work on the submission,\u201d said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. \u201cWe are committed to improving patient access to novel and accessible oral medicines.\u201d<\/p>\n<p align=\"justify\">Data from the Phase IIb\/III trial demonstrated oral once daily blarcamesine pre-specified clinical efficacy through upstream SIGMAR1 activation. SIGMAR1 is an integral membrane protein which activates an upstream compensatory process: Blarcamesine induces autophagy through SIGMAR1 activation resulting in restoring cellular homeostasis.<\/p>\n<p align=\"justify\">Impaired autophagy precedes both amyloid beta and tau tangles, and therefore anticipates the neurodegenerative process in Alzheimer\u2019s disease.<sup>1<\/sup> Hence, stabilization or restoration of autophagy can be seen as an early preventative measure countering the Alzheimer\u2019s disease pathology.<\/p>\n<p align=\"justify\">Blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points.<sup>2<\/sup> This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine\u2019s safety profile indicates not requiring routine MRI monitoring, and given its differentiated mechanism of action, oral blarcamesine could represent a novel treatment that could be complementary or an alternative to injectable anti-beta amyloid monoclonal antibody drugs.<\/p>\n<p align=\"justify\">This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.<\/p>\n<p>\n        <strong>About Alzheimer\u2019s Disease<\/strong>\n      <\/p>\n<p align=\"justify\">There are an estimated 7 million people in Europe with Alzheimer\u2019s disease, a number expected to double by 2030, according to the European Brain Council.<sup>3<\/sup> The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer&#8217;s disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.<sup>4<\/sup><sup>,<\/sup><sup>5<\/sup><\/p>\n<p>\n        <strong>About Anavex Life Sciences Corp.<\/strong>\n      <\/p>\n<p align=\"justify\">Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer&#8217;s disease, Parkinson&#8217;s disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex&#8217;s lead drug candidate, ANAVEX<sup>\u00ae<\/sup>2-73 (<em>blarcamesine<\/em>), has successfully completed a Phase 2a and a Phase 2b\/3 clinical trial for Alzheimer&#8217;s disease, a Phase 2 proof-of-concept study in Parkinson&#8217;s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2\/3 study in pediatric patients with Rett syndrome. ANAVEX<sup>\u00ae<\/sup>2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and\/or reverse the course of Alzheimer&#8217;s disease. ANAVEX<sup>\u00ae<\/sup>2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson&#8217;s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX<sup>\u00ae<\/sup>2-73 for the treatment of Parkinson&#8217;s disease. We believe that ANAVEX<sup>\u00ae<\/sup>3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer&#8217;s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX<sup>\u00ae<\/sup>3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RD7n-sqANhQVk7d5Pn2ZHZHbGvQAS7Bx2vmdxoeyLSlCsE_VbR58uad3DA2-T5F4GXYT9cvGIdzhTVNjzyJFww==\" rel=\"nofollow\" target=\"_blank\">www.anavex.com<\/a>. You can also connect with the Company on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=s41F_PetkawUC53ibL2YgWzsKXkzg1ed-ZVk_nq501hqmXzrPH4ZSsMu3tBOHghaWyuyRvQffRfJ8FL4RYBa6jtpChOmVCUI7Up5HFupmo4=\" rel=\"nofollow\" target=\"_blank\">Twitter,<\/a><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GJJlefFd-SeM5-Teif2zcxY8zWvIKrsUscoAWqhaO_0bYJL8zNAaAbc7fHA_DuC6iVPF05V32OHaFfrArE7NIC5kEERlFTUxuA-Ebr8rZ5mTA8KfWkPp12w9490omjHYy4lKbQScm5DW0-CN_j5--g==\" rel=\"nofollow\" target=\"_blank\">Facebook<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RP_NrTH-tLrWkI-9ZXtCUT6yLFPdg683EbbXl49NAqyvGuB3HAAbEEkmf3OQMiZhsyGqzbthoGhSZNw3pOw10y3h2-rR0zLql8AX69m1NiE=\" rel=\"nofollow\" target=\"_blank\">Instagram<\/a>, and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xX7iWOxBNyLvVwQuTr_U7kXseUnrHkz_qoiCrKVKjxoZ6giZjoidArv20l3qXpo0bg0urugzbuT0J7uqAsNHrGRU91EjQsGZ6ICZ741lVXDsAVtYucWXI9N9mpMMqvOr\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company\u2019s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.<\/p>\n<p align=\"justify\">\n        <strong>For Further Information:<\/strong><br \/>\n        <br \/>Anavex Life Sciences Corp.<br \/>Research &amp; Business Development<br \/>Toll-free: 1-844-689-3939<br \/>Email: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RpUZIvUe5nYUibvXO-kLrSoS2STM8zm1iksrXYxGtJUXQlurQiaEzLjMmsxiXFgH39_wE7tANDKfkniGua0phg==\" rel=\"nofollow\" target=\"_blank\">info@anavex.com<\/a><\/p>\n<p align=\"justify\">\n        <strong>Investors:<\/strong><br \/>\n        <br \/>Andrew J. Barwicki<br \/>Investor Relations<\/p>\n<p align=\"justify\">Tel: 516-662-9461<br \/>Email: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=S5Q7MRdSvLAN3ANxeTm4GZ9S-quXvYQ60Sbjo5tQy3qg0yzabHIjYEieLAOsuNr60x7xmRw0Re2KNwEdx6Qe1ApdXdfEuH51ts8AqTzUmWY=\" rel=\"nofollow\" target=\"_blank\">andrew@barwicki.com<\/a><\/p>\n<hr \/>\n<p>\n        <sup>1<\/sup> Christ MG, Clement AM, Behl C. The Sigma-1 Receptor at the Crossroad of Proteostasis, Neurodegeneration, and Autophagy. Trends Neurosci. 2020 Feb;43(2):79-81; Chen, J., He, HJ., Ye, Q. et al. Defective Autophagy and Mitophagy in Alzheimer\u2019s Disease: Mechanisms and Translational Implications. Mol Neurobiol 58, 5289\u20135302 (2021).<br \/><sup>2<\/sup> Muir RT, Hill MD, Black SE, Smith EE. Minimal clinically important difference in Alzheimer&#8217;s disease: Rapid review.\u00a0Alzheimers Dement. 2024;20(5):3352-3363. doi:10.1002\/alz.13770<br \/><sup>3<\/sup> https:\/\/www.braincouncil.eu\/projects\/rethinking-alzheimers-disease\/<br \/><sup>4<\/sup> J\u00f6nsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016\/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.<br \/><sup>5<\/sup> World Health Organization (WHO); 2021. Global status report on the public health response to dementia.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMjk3NCM2NjQ4MDgyIzIwMTk1Mzk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NzZjYjQ1ZTQtODZjNy00NDZmLTg0NTctZmNkMDdiNDQ2MmQxLTEwMzExNzY=\/tiny\/Anavex-Life-Sciences-Corp-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Blarcamesine: Potential novel oral treatment to target upstream Alzheimer\u2019s disease pathology through autophagy enhancement Submission based on favorable ANAVEX\u00ae2-73-AD-004 trial results in patients with early Alzheimer\u2019s disease Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer&#8217;s disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) &#8212; Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer&#8217;s disease, Parkinson&#8217;s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease&#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-796669","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease - 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\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Blarcamesine: Potential novel oral treatment to target upstream Alzheimer\u2019s disease pathology through autophagy enhancement Submission based on favorable ANAVEX\u00ae2-73-AD-004 trial results in patients with early Alzheimer\u2019s disease Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer&#8217;s disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) &#8212; Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer&#8217;s disease, Parkinson&#8217;s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine &hellip; Continue reading &quot;Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-23T12:03:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMjk3NCM2NjQ4MDgyIzIwMTk1Mzk=\" \/>\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=\"6 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\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease\",\"datePublished\":\"2024-12-23T12:03:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/\"},\"wordCount\":1239,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTMyMjk3NCM2NjQ4MDgyIzIwMTk1Mzk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimers-disease\\\/\",\"name\":\"Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer\u2019s Disease - 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