{"id":382786,"date":"2020-11-17T08:03:27","date_gmt":"2020-11-17T13:03:27","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=382786"},"modified":"2020-11-17T08:03:27","modified_gmt":"2020-11-17T13:03:27","slug":"azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/","title":{"rendered":"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <strong><br \/>\n          <em>Potential to add additional study arm utilizing immediate release capsules<\/em><br \/>\n        <\/strong><br \/>\n        \n      <\/p>\n<p align=\"center\">\n        <strong><br \/>\n          <em>Trial objectives, endpoints and statistical analysis to remain the same<\/em><br \/>\n        <\/strong>\n      <\/p>\n<p>DELRAY BEACH, Fla., Nov.  17, 2020  (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (NASDAQ:AZRX) (\u201cAzurRx\u201d or the \u201cCompany\u201d), a company specializing in the development of non-systemic, recombinant\u00a0therapies for\u00a0gastrointestinal diseases, today announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.\u00a0 The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.<\/p>\n<p>\u201cWe are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed,\u201d said Dr. James Pennington, Chief Medical Officer of AzurRx. \u201cAs this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819.\u201d<\/p>\n<p>Dr. Pennington added, \u201cThe key objectives of any Phase 2 program are to test for safety and efficacy, but another important goal is to determine appropriate doses and drug delivery method prior to entering the Phase 3 portion of the clinical program. If the amendment is accepted by the FDA, we anticipate enrollment into the new study arm to begin in December 2020.\u201d<\/p>\n<p>James Sapirstein, CEO of AzurRx commented, \u201cThe protocol amendment represents an opportunity to gain valuable additional clinical data with no significant increase in overall trial costs or delays to our timeline projections. We remain on target to release top line data in the first quarter of 2021, as has been our guidance to date.\u201d<\/p>\n<p>\n        <strong>About AzurRx BioPharma, Inc.<\/strong><br \/>\n        <br \/>AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company\u00a0specialized\u00a0in the research and development of non-systemic biologics for\u00a0gastrointestinal disorders. The Company is focused on the development of its lead drug\u00a0candidate, MS1819. AzurRx is currently conducting two Phase 2\u00a0clinical trials\u00a0of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial,\u00a0consisting\u00a0of MS1819 in conjunction with porcine-derived\u00a0pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. Additional information on the Company can be found at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=_AIcXNsBrvrydrY-Cxcf3yumPZaPL0bRCO0qFHkkjnqdmkHZaMMXdF8XKJgPb-gbi5O1OWgxJg2Kt5s5VilUGfkSYS2p2vfod9m5C7JY-6lmx1xz0C8_4U5mKgRZkBNQawKHxPwNGWObpM3CdXbbW8o9tJJVhD75_8v6KuDjBqnM83JKVEgRWXT3Y3jKBCbbXlYptr1p338cMsfUzwQZwVZxprQzVEVxCzUJbV1hlA4=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>www.azurrx.com<\/u><\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>\n        <em>This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company\u2019s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company\u2019s control. It is possible that the Company<\/em><br \/>\n        <em>\u2019<\/em><br \/>\n        <em>s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, 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 such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company<\/em><br \/>\n        <em>\u2019<\/em><br \/>\n        <em>s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company<\/em><br \/>\n        <em>\u2019<\/em><br \/>\n        <em>s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company<\/em><br \/>\n        <em>\u2019<\/em><br \/>\n        <em>s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading<\/em><br \/>\n        <em>\u00a0\u201c<\/em><br \/>\n        <em>Risk Factors,<\/em><br \/>\n        <em>\u201d\u00a0<\/em><br \/>\n        <em>as well as the Company<\/em><br \/>\n        <em>\u2019<\/em><br \/>\n        <em>s 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>\n        <strong><br \/>\n          <em>For more information:<\/em><br \/>\n        <\/strong>\n      <\/p>\n<p>AzurRx BioPharma, Inc.<br \/>760 Parkside Avenue, Suite 327F<br \/>Brooklyn, NY 11226<br \/>Phone: (646)-699-7855<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=K4-2c4dpUiAcMe6QnEjb2cducUMuwT_8FokgJiBu4ss52OnwwGwsbmwxBWUKYd1j043y2Okxw9kcnFwH-WFD_g==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">info@azurrx.com<\/a><\/p>\n<p>\n        <strong>Investor Relations contact:<\/strong>\n      <\/p>\n<p>LifeSci Advisors, LLC.\u00a0<br \/>Hans Vitzthum, Managing Director\u00a0<br \/>1 International Place, Suite 1480\u00a0<br \/>Boston, MA 02110\u00a0<br \/>Phone: 617-430-7578\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SmFfE8f9ymzutkFeylhpRu958sYCC2zpTu8IdlC-EZa2-8Jd1Fzj-vJRwe_zfGlSz7tj6J56jqbq-FXhJYIe_VfD4hAkl4Ogr4rNIdeKnI0=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>hans@lifesciadvisors.com<\/u><\/a><\/p>\n<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzM4MCMzODMwODAyIzIwODIyMDc=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/2a872dab-dd58-4baf-9588-5fa2716480b1\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Potential to add additional study arm utilizing immediate release capsules Trial objectives, endpoints and statistical analysis to remain the same DELRAY BEACH, Fla., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (NASDAQ:AZRX) (\u201cAzurRx\u201d or the \u201cCompany\u201d), a company specializing in the development of non-systemic, recombinant\u00a0therapies for\u00a0gastrointestinal diseases, today announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.\u00a0 The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients&#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-382786","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients - 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-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Potential to add additional study arm utilizing immediate release capsules Trial objectives, endpoints and statistical analysis to remain the same DELRAY BEACH, Fla., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (NASDAQ:AZRX) (\u201cAzurRx\u201d or the \u201cCompany\u201d), a company specializing in the development of non-systemic, recombinant\u00a0therapies for\u00a0gastrointestinal diseases, today announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.\u00a0 The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with &hellip; Continue reading &quot;AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-17T13:03:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzM4MCMzODMwODAyIzIwODIyMDc=\" \/>\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-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients\",\"datePublished\":\"2020-11-17T13:03:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/\"},\"wordCount\":751,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODA4NzM4MCMzODMwODAyIzIwODIyMDc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\\\/\",\"name\":\"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients - 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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-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/","og_locale":"en_US","og_type":"article","og_title":"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients - Market Newsdesk","og_description":"Potential to add additional study arm utilizing immediate release capsules Trial objectives, endpoints and statistical analysis to remain the same DELRAY BEACH, Fla., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; AzurRx BioPharma, Inc. (NASDAQ:AZRX) (\u201cAzurRx\u201d or the \u201cCompany\u201d), a company specializing in the development of non-systemic, recombinant\u00a0therapies for\u00a0gastrointestinal diseases, today announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.\u00a0 The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with &hellip; Continue reading \"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-17T13:03:27+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzM4MCMzODMwODAyIzIwODIyMDc=","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-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients","datePublished":"2020-11-17T13:03:27+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/"},"wordCount":751,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzM4MCMzODMwODAyIzIwODIyMDc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-requests-protocol-amendment-to-phase-2b-option-2-study-of-ms1819-in-cystic-fibrosis-patients\/","name":"AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients - 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