{"id":528720,"date":"2021-08-17T07:03:10","date_gmt":"2021-08-17T11:03:10","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/"},"modified":"2021-08-17T07:03:10","modified_gmt":"2021-08-17T11:03:10","slug":"azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/","title":{"rendered":"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">BOCA RATON, Fla., Aug.  17, 2021  (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (\u201cAzurRx\u201d or the \u201cCompany\u201d) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic\u00a0therapies for\u00a0gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published \u201cadrulipase alfa\u201d as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.<\/p>\n<p align=\"justify\">\u201cThe assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology,\u201d said James Sapirstein, President and CEO of AzurRx. \u201cAssignment of an INN signifies that a pharmaceutical substance has reached a point in its development where it is now beneficial to specify to pharmacists and medical doctors, via nomenclature, the substances contained in a preparation. For MS1819, we view this as further validation of the technology. It is a clear point of differentiation as we continue the drug\u2019s development as a potential treatment for EPI that could improve upon the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT).\u201d<\/p>\n<p align=\"justify\">AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819. The Company reported topline results from its Phase 2b OPTION 2 monotherapy trial in March 2021 and expects to report full topline results from its Phase 2 combination therapy trial, evaluating MS1819 in combination with PERT, for the treatment of severe EPI in patients with cystic fibrosis, in the third quarter of 2021.<\/p>\n<p align=\"justify\">The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021.<\/p>\n<p align=\"justify\">\n        <strong>About MS1819 (adrulipase alfa)<\/strong><br \/>\n        <br \/>MS1819 is a recombinant lipase enzyme that has been developed for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral, non-systemic, biologic capsule, is derived from the <em>Yarrowia lipolytica<\/em> yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 lipase does not contain any animal products.<\/p>\n<p align=\"justify\">\n        <strong>About Exocrine Pancreatic Insufficiency<\/strong><br \/>\n        <br \/>EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.<\/p>\n<p align=\"justify\">There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.<\/p>\n<p align=\"justify\">\n        <strong>About AzurRx BioPharma, Inc.<\/strong><br \/>\n        <br \/>AzurRx BioPharma, Inc. (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7ne-ptdVY8USvL4m-hlOvk5Cm_7jEkfpq7oWbzFQbpsofvW8tQ9msC3rV2E50EKhZELuB2UvOfxOGMhQv3vmL5HZ85wOyN1WqliK2DnVdQkBqlKxq6BZDrNL4TTeZlAN\" rel=\"nofollow noopener\" target=\"_blank\">NASDAQ: AZRX<\/a>) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a small molecule with anti-viral and anti-inflammatory properties: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=NxW_952nrA6rgFUFvcJifSJrpV2mRKr2RtV2kbT6jQhM3s-xTT3JsqvkLSDMYIBF1g7faZWR8qks-Y6P-CTYMg==\" rel=\"nofollow noopener\" target=\"_blank\">www.azurrx.com<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statement<\/strong><br \/>\n        <br \/>\n        <em>This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company\u2019s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company\u2019s drug candidates and its ability to service those markets; and the Company\u2019s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company\u2019s financial results are contained in the Company\u2019s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading \u201cRisk Factors,\u201d as well as the Company\u2019s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.<\/em>\n      <\/p>\n<p align=\"justify\">\n        <strong>For more information:<\/strong><br \/>\n        <br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ZGXe_GvEggXSWH2vgA4I3vCA0rADv_HBb9ec-wmbtiFHrXW-EBXASDnaJeaiGfBFrdlsLBtyI-Bgl8EEFlVtzw==\" rel=\"nofollow noopener\" target=\"_blank\">AzurRx BioPharma, Inc.<\/a><br \/>\n        <br \/>777 Yamato Road, Suite 502<br \/>Boca Raton, FL 33431<br \/>Phone: (561) 589-7020<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xwp47LXTK59GN3sLzUa00QKXGUKihLddPurKw9Tlnzqh_o8yjAIFeFf8Ikb9H057Br1QVOCzq5cR89FH7zaOIQ==\" rel=\"nofollow noopener\" target=\"_blank\">info@azurrx.com<\/a><\/p>\n<p align=\"justify\">\n        <strong>Media contact:<\/strong><br \/>\n        <br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=F-s6uar1zznphkHFkEVy4wmsTFZEwNnSfkKs9C8KbJ3SmIXubokr9kd6VHJGQKZtlqA9fooyxVSlKsu2hrGxipUqYTcU1nlAUZ-d4a2I7mg=\" rel=\"nofollow noopener\" target=\"_blank\">Tiberend Strategic Advisors, Inc.<\/a><br \/>\n        <br \/>Johanna Bennett \/ David Schemelia<br \/>(212) 375-2665 \/ (609) 468-9325<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=WXUuiF8RMHmP0c5VgJnqlHV-SUx4dkpeWtw5l5ashGj3wNnOhl0I-EA6pesVe3pLYb71jMC9UqVw4nCPMezmk7RFW7ThTySNWaCdmfGsyvg=\" rel=\"nofollow noopener\" target=\"_blank\">jbennett@tiberend.com<\/a> \/ <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HT6SgrhnFvT-l5iAeIobZdSkmZVC6OcjMsraQYy_B5XqHyvzXDmn3-UR7iKhqf0oU7qpc2R-ZGp6kG8WSFqKLOCRYRjOGfcA57M_UVssHIg=\" rel=\"nofollow noopener\" target=\"_blank\">dschemelia@tiberend.com<\/a><\/p>\n<p>\u00a0<\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMxMDM5NiM0MzYyMDIyIzIwODIyMDc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MmU5YWFjODMtNzZiNC00YzQzLTk1OWYtZjBkYmRjYjBlYmIzLTEwOTM3Nzg=\/tiny\/AzurRx-BioPharma-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (\u201cAzurRx\u201d or the \u201cCompany\u201d) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic\u00a0therapies for\u00a0gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published \u201cadrulipase alfa\u201d as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. \u201cThe assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology,\u201d said James Sapirstein, President and CEO of AzurRx. \u201cAssignment of an INN signifies that a pharmaceutical substance has reached &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819&#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-528720","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819 - 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\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (\u201cAzurRx\u201d or the \u201cCompany\u201d) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic\u00a0therapies for\u00a0gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published \u201cadrulipase alfa\u201d as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. \u201cThe assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology,\u201d said James Sapirstein, President and CEO of AzurRx. \u201cAssignment of an INN signifies that a pharmaceutical substance has reached &hellip; Continue reading &quot;AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-17T11:03:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMxMDM5NiM0MzYyMDIyIzIwODIyMDc=\" \/>\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\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819\",\"datePublished\":\"2021-08-17T11:03:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/\"},\"wordCount\":846,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODMxMDM5NiM0MzYyMDIyIzIwODIyMDc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\\\/\",\"name\":\"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819 - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/","og_locale":"en_US","og_type":"article","og_title":"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819 - Market Newsdesk","og_description":"BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (\u201cAzurRx\u201d or the \u201cCompany\u201d) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic\u00a0therapies for\u00a0gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published \u201cadrulipase alfa\u201d as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. \u201cThe assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology,\u201d said James Sapirstein, President and CEO of AzurRx. \u201cAssignment of an INN signifies that a pharmaceutical substance has reached &hellip; Continue reading \"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/","og_site_name":"Market Newsdesk","article_published_time":"2021-08-17T11:03:10+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMxMDM5NiM0MzYyMDIyIzIwODIyMDc=","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\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819","datePublished":"2021-08-17T11:03:10+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/"},"wordCount":846,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMxMDM5NiM0MzYyMDIyIzIwODIyMDc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-who-publication-of-adrulipase-alfa-as-international-nonproprietary-name-for-ms1819\/","name":"AzurRx BioPharma Announces WHO Publication of \u201cAdrulipase Alfa\u201d as International Nonproprietary Name for MS1819 - 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