{"id":451230,"date":"2021-03-04T16:08:18","date_gmt":"2021-03-04T21:08:18","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=451230"},"modified":"2021-03-04T16:08:18","modified_gmt":"2021-03-04T21:08:18","slug":"apellis-provides-update-on-apl-9-for-severe-covid-19","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/","title":{"rendered":"Apellis Provides Update on APL-9 for Severe COVID-19"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">\n          <em>Company will not pursue additional development of APL-9 for the treatment of severe COVID-19<br \/><\/em><br \/>\n          \n        <\/li>\n<li>\n          <em>Interim review by independent data monitoring committee (DMC) found no meaningful reduction in the overall mortality rate in Phase 1\/2 study<br \/><\/em><br \/>\n          \n        <\/li>\n<li>\n          <em>No safety signals were observed by the DMC<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p>WALTHAM, Mass., March  04, 2021  (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals,\u00a0Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies,\u00a0today announced that the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1\/2 study by an independent data monitoring committee (DMC), which found no meaningful reduction in the overall mortality rate in patients treated with APL-9 in combination with standard of care therapy compared to standard of care alone. No safety signals were observed by the DMC.<\/p>\n<p>\u201cWe initiated the clinical development of APL-9 in patients with severe COVID-19 because we believed that complement dysregulation may play a key role in disease mortality. We felt a responsibility to learn if controlling complement could help save lives during this devastating pandemic,\u201d said Lukas Scheibler, Ph.D., chief innovation officer at Apellis. \u201cWhile the mortality results from this study were not what we had hoped, we extend our heartfelt thanks to the patients and their families, healthcare providers, and investigators who joined us in working to address an urgent public health need. We remain confident in the potential of targeting C3 for complement-driven diseases and are committed to bringing transformative treatments to patients.\u201d<\/p>\n<p>No additional endpoints were analyzed as part of the interim review by the DMC. Enrollment is complete, and the study reached the last patient visit. Apellis plans to provide full results in a scientific forum following completion of the full data analysis.<\/p>\n<p>\n        <strong>About APL-9<\/strong><br \/>\n        <br \/>APL-9 is an investigational drug designed to control the complement cascade centrally at C3 and may have the potential to treat a range of diseases caused by excessive or uncontrolled activation of complement. APL-9 leverages the same mechanism of action as Apellis\u2019 lead compound, pegcetacoplan (APL-2), but has a lower molecular weight and shorter half-life. APL-9 is designed to be intravenously administered for acute use.<\/p>\n<p><strong>About Apellis<\/strong>\u00a0<br \/>Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, nephrology, and neurology. For more information, please\u00a0visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5IZ-T8zazm8t7_S5rwkqlpzxGoVScoxhDy3YyqqFIvW9zHevFJy1HgXnZchMbjvWVfDQtAL0sap8HF3M1ySkMgqkSw67zLJQHkhzruWDJz2uLRkiE9eOXs8Kzwg8o0i3qVOdzAnSdAoo19J7GGv-tMJPESuEdLH8efqTSJKyStcdUZLckXIaVkVqCgO99QnfjG7ID57wZzlJeGt9Tw8LNOYLs4WzlhJLnvcA8bq1sdk=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">http:\/\/apellis.com<\/a>.<\/p>\n<p>\n        <strong>Apellis Forward-Looking Statement<\/strong>\u00a0<br \/>Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute \u201cforward-looking statements\u201d within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. The words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould\u201d and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the company\u2019s clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whether\u00a0pegcetacoplan\u00a0will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the company\u2019s clinical trials will warrant regulatory submissions and whether\u00a0pegcetacoplan\u00a0will receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other indication when expected or at all; whether, if Apellis\u2019 products receive approval, they will be successfully distributed and marketed; and other factors discussed in the \u201cRisk Factors\u201d section of Apellis\u2019 Annual Report on Form 10-K filed with the\u202fSecurities and Exchange Commission\u202fon February 25, 2020\u202fand the risks described in other filings that Apellis may make with the\u202fSecurities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.<\/p>\n<p>\n        <strong>Media Contact:\u00a0<\/strong><br \/>\n        <br \/>Lissa Pavluk\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=IcF-GZmuXXcgwn3plti541fLcIDYVQWqAWvOXIHg5l6haht4ZD52Pt2oleS4KOn2xfXBetBK-Yrznz5PH70oLg==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">media@apellis.com<\/a>\u00a0\u00a0<br \/>617.977.6764<\/p>\n<p>\n        <strong>Investor Contact:<\/strong><br \/>\n        <br \/>Argot Partners<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=O0AuUfsWr6jv5oE4b0Fje_7VDp2fjFg-Gybdsg8muGiTUOx0INFqz1ZCLeTvDWUT7U3vvOgoO4-WgHRGrQeGmpl7FqIfbNHu1jEiCpoNxlg=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">apellis@argotpartners.com<\/a><br \/>+1\u202f212.600.1902<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4MzkxMCM0MDQ2NzQ0IzIwMjAwMjY=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/be7ba68d-9cae-419b-b23b-ace6fce3ae77\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Company will not pursue additional development of APL-9 for the treatment of severe COVID-19 Interim review by independent data monitoring committee (DMC) found no meaningful reduction in the overall mortality rate in Phase 1\/2 study No safety signals were observed by the DMC WALTHAM, Mass., March 04, 2021 (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals,\u00a0Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies,\u00a0today announced that the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1\/2 study by an independent data monitoring committee (DMC), which found no meaningful reduction in the overall &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Apellis Provides Update on APL-9 for Severe COVID-19&#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-451230","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>Apellis Provides Update on APL-9 for Severe COVID-19 - 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\/apellis-provides-update-on-apl-9-for-severe-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apellis Provides Update on APL-9 for Severe COVID-19 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Company will not pursue additional development of APL-9 for the treatment of severe COVID-19 Interim review by independent data monitoring committee (DMC) found no meaningful reduction in the overall mortality rate in Phase 1\/2 study No safety signals were observed by the DMC WALTHAM, Mass., March 04, 2021 (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals,\u00a0Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies,\u00a0today announced that the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1\/2 study by an independent data monitoring committee (DMC), which found no meaningful reduction in the overall &hellip; Continue reading &quot;Apellis Provides Update on APL-9 for Severe COVID-19&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-04T21:08:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4MzkxMCM0MDQ2NzQ0IzIwMjAwMjY=\" \/>\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=\"4 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\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Apellis Provides Update on APL-9 for Severe COVID-19\",\"datePublished\":\"2021-03-04T21:08:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/\"},\"wordCount\":782,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODE4MzkxMCM0MDQ2NzQ0IzIwMjAwMjY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-provides-update-on-apl-9-for-severe-covid-19\\\/\",\"name\":\"Apellis Provides Update on APL-9 for Severe COVID-19 - 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(Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies,\u00a0today announced that the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1\/2 study by an independent data monitoring committee (DMC), which found no meaningful reduction in the overall &hellip; Continue reading \"Apellis Provides Update on APL-9 for Severe COVID-19\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/","og_site_name":"Market Newsdesk","article_published_time":"2021-03-04T21:08:18+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4MzkxMCM0MDQ2NzQ0IzIwMjAwMjY=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Apellis Provides Update on APL-9 for Severe COVID-19","datePublished":"2021-03-04T21:08:18+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/"},"wordCount":782,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4MzkxMCM0MDQ2NzQ0IzIwMjAwMjY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-provides-update-on-apl-9-for-severe-covid-19\/","name":"Apellis Provides Update on APL-9 for Severe COVID-19 - 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