{"id":411665,"date":"2021-01-11T07:03:10","date_gmt":"2021-01-11T12:03:10","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=411665"},"modified":"2021-01-11T07:03:10","modified_gmt":"2021-01-11T12:03:10","slug":"amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/","title":{"rendered":"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">SAN DIEGO, Jan.  11, 2021  (GLOBE NEWSWIRE) &#8212; Amydis Inc., a leading ocular tracer pharmaceutical company with a broad portfolio of diagnostic drug candidates targeting CNS biomarkers in the eye, today announced successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for its lead candidate, AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta for the diagnosis of amyloid angiopathy. Amydis has reached agreement with the FDA on both nonclinical and clinical plans. The FDA also supports Amydis\u2019 adaptive Phase 1\/2a first-in-human (FIH) clinical development plans for evaluating AMDX-2011P as a potential retinal tracer to diagnose patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which amyloid proteins build up on the walls of the arteries in the brain increasing the risk for stoke caused by bleeding and dementia.<\/p>\n<p align=\"justify\">\u201cThis feedback from the FDA is a significant milestone for Amydis,\u201d said Stella Sarraf PhD, Founder and Chief Executive Officer of Amydis, \u201cWe are pleased to have reached agreement with the FDA on our clinical plan for AMDX-2011P in CAA patients and we appreciate the FDA\u2019s guidance on our path to introduce this new class of ocular tracers.\u201d<\/p>\n<p align=\"justify\">CAA is a major cause of spontaneous intracerebral hemorrhage in people older than 55 and an important contributor to age-related cognitive decline. Current diagnosis of CAA involves expensive imaging tests (MRI, CT scans, and PET amyloid tests) yet physicians are unable to confidently diagnose CAA without a sample of brain tissue. The Amydis technology is designed to provide an affordable and accessible retinal test as a welcome addition to the armamentarium of diagnostic tests available to physicians.<\/p>\n<p align=\"justify\">Steven M. Greenberg M.D., Ph.D., Professor of Neurology at Harvard Medical School &amp; Director of the Hemorrhagic Stroke Research Program at Massachusetts General Hospital and a leading CAA authority who is unaffiliated with Amydis said, \u201cI am excited to collaborate with Amydis on the FIH clinical trials. I am keenly aware of the challenges CAA patients face in the diagnosis and treatment of disease. I believe that diagnosis of CAA through the eye would be a tremendous step forward for the field.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Amydis, Inc. <\/strong>\n      <\/p>\n<p align=\"justify\">Amydis<strong>\u00a0<\/strong>is a hybrid biotechnology company developing a new class of diagnostics, which enable the eye to serve as a window to the brain to accelerate the early detection of neurological, ocular, and systemic diseases, accelerate and improve the clinical evaluation of novel therapeutics, and revolutionize treatment.\u00a0Amydis\u00a0uses novel small molecule contrast agents \u2013 \u201cocular tracers\u201d \u2013 which bind selectively to disease-related amyloid proteins\u00a0(e.g. amyloid beta, alpha synuclein, prion, Tau, etc) and emit a strong fluorescent signal upon binding which can be imaged with existing cameras in clinical practice. This enables direct visualization of disease-related biomarkers in the retina, which\u00a0Amydis\u00a0has confirmed in multiple NIH and Michael J Fox funded animal model studies of Alzheimer&#8217;s Disease, Parkinson\u2019s Disease, cerebral amyloid angiopathy, traumatic brain injury, and Creutzfeldt-Jacob disease.\u00a0 For more information on the Company, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HRLuIEpOqeY5dWAYs_PbWO8J8H93T7Z3vBgUQmy82wmrAf8DoBlJTsqlvm7H2zAGdcbST8BUX2kDhmEha7gLmA==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.amydis.com<\/a>.<\/p>\n<p align=\"justify\">Amydis Contact: Ron Newbold, Chief Business Officer, ron@amydis.com.<\/p>\n<p \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyMzA2OSMzOTExMjU2IzIwMjg0MDM=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/cd831c24-efbb-42db-87c8-1377d2c8cfa9\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) &#8212; Amydis Inc., a leading ocular tracer pharmaceutical company with a broad portfolio of diagnostic drug candidates targeting CNS biomarkers in the eye, today announced successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for its lead candidate, AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta for the diagnosis of amyloid angiopathy. Amydis has reached agreement with the FDA on both nonclinical and clinical plans. The FDA also supports Amydis\u2019 adaptive Phase 1\/2a first-in-human (FIH) clinical development plans for evaluating AMDX-2011P as a potential retinal tracer to diagnose patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which amyloid proteins &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy&#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-411665","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy - 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\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) &#8212; Amydis Inc., a leading ocular tracer pharmaceutical company with a broad portfolio of diagnostic drug candidates targeting CNS biomarkers in the eye, today announced successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for its lead candidate, AMDX-2011P, a small-molecule retinal tracer that targets amyloid beta for the diagnosis of amyloid angiopathy. Amydis has reached agreement with the FDA on both nonclinical and clinical plans. The FDA also supports Amydis\u2019 adaptive Phase 1\/2a first-in-human (FIH) clinical development plans for evaluating AMDX-2011P as a potential retinal tracer to diagnose patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which amyloid proteins &hellip; Continue reading &quot;Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-11T12:03:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyMzA2OSMzOTExMjU2IzIwMjg0MDM=\" \/>\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=\"3 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\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy\",\"datePublished\":\"2021-01-11T12:03:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/\"},\"wordCount\":542,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODEyMzA2OSMzOTExMjU2IzIwMjg0MDM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\\\/\",\"name\":\"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy - 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Amydis has reached agreement with the FDA on both nonclinical and clinical plans. The FDA also supports Amydis\u2019 adaptive Phase 1\/2a first-in-human (FIH) clinical development plans for evaluating AMDX-2011P as a potential retinal tracer to diagnose patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which amyloid proteins &hellip; Continue reading \"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-11T12:03:10+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyMzA2OSMzOTExMjU2IzIwMjg0MDM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy","datePublished":"2021-01-11T12:03:10+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/"},"wordCount":542,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyMzA2OSMzOTExMjU2IzIwMjg0MDM=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/amydis-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-the-development-of-amdx-2011p-a-first-in-class-retinal-tracer-for-the-diagnosis-of-amyloid-angiopathy\/","name":"Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy - 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