{"id":389417,"date":"2020-11-30T08:03:33","date_gmt":"2020-11-30T13:03:33","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=389417"},"modified":"2020-11-30T08:03:33","modified_gmt":"2020-11-30T13:03:33","slug":"azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/","title":{"rendered":"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">\n          <em>Patient screening and dosing ongoing in Turkey and Hungary<\/em><br \/>\n          \n        <\/li>\n<li>\n          <em>Topline data expected in Q2 2021 for the Combination Trial<\/em>\n        <\/li>\n<\/ul>\n<p>DELRAY BEACH, Fla., Nov.  30, 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 the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).<\/p>\n<p>\u201cIn the midst of a global pandemic and unpredictable obstacles, we are very encouraged to see our Combination therapy trial moving forward at one of the clinical testing sites in Turkey,\u201d said James Sapirstein, President &amp; CEO of AzurRx. \u00a0Mr. Sapirstein continued, \u201cWe expect to release topline results in the second quarter of next year. We are optimistic the results will build on the encouraging data we received earlier this year and hope we will be one step closer to improving the lives of thousands of patients suffering from cystic fibrosis.\u201d<\/p>\n<p>Earlier last month, the Company reported that additional clinical sites were activated in Turkey, which follows Hungary as the second country where patients have been screened and dosed in the Combination trial. \u00a0As of today, there are five sites activated in Turkey that are currently screening for patients.<\/p>\n<p>The Phase 2 Combination Trial, open-label, multicenter study is assessing the safety and efficacy of MS1819 administered over 15 days in immediate release capsules in increasing doses of 700mg, 1,200mg and 2,240 mg per day, in combination with a patient\u2019s daily dose of PERT.\u00a0 Previously reported results on the initial five patients in the trial revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the coefficient of fat absorption (CFA), and improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea (excessive amounts of fat in the feces).<\/p>\n<p>\n        <strong>About the MS1819 Combination Therapy Trial<\/strong><br \/>\n        <br \/> The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs<sup>(1,2)<\/sup>.\u00a0 Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function<sup>(3,4)<\/sup>.<\/p>\n<p>A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in Q2 2021.<\/p>\n<p>\n        <strong>About MS1819<\/strong><br \/>\n        <br \/> MS1819 is a recombinant lipase enzyme 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\u00a0<em>Yarrowia lipolytica<\/em>\u00a0yeast 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 synthetic lipase does not contain any animal products.<\/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=E0j5qWs88hBFDnlkTULS6OE5OXgm93QweRamyJGGDiNYgxkoZsuIvB3d7OL8NiqP9tzBacXcvlx2ujp26nMDvg==\" 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\u2019s 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\u2019s 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\u2019s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company\u2019s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading\u00a0\u201cRisk Factors,\u201d\u00a0as 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>\n        <em><br \/>\n          <strong>For more information:<\/strong><br \/>\n        <\/em>\n      <\/p>\n<p>AzurRx BioPharma, Inc.<br \/> 1615 South Congress Avenue<br \/>Suite 103<br \/> Delray Beach, Florida 33445<br \/> Phone: (646)-699-7855<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=vBP-xbjGGddFu5SoCUkc0eQlqQl45ypgxDSREZYAgXoomlfCVevaUPVA9fY8tUMiNhw9QtcXOzhcf8SFfAHJBw==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>info@azurrx.com<\/u><\/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=_sJvKYLoE6PtK39j7uy2s9ehM3OntIoKjxfhbZxnIOeox6lmZujEl8-2h0gb0NcE8lFCmQaSMXdS7o9Jccvn2zjp4UKogq75YmWrVwoi950=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>hans@lifesciadvisors.com<\/u><\/a><\/p>\n<p>\n        <strong>References<\/strong><br \/>\n        <br \/> (1) Freedman, S.D.,\u00a0<em>Am. J.\u00a0Manag. Care<\/em>, 2017; 23: S2220-S228<br \/> (2) Littlewood, J. et al, 2006,\u00a0<em>Pediatric Pulmonology<\/em>, 2006, 41:35-49<br \/> (3) Engelen, M. et al, 2014,\u00a0<em>Curr.\u00a0Opin. Clin.\u00a0Nutr.\u00a0Metab. Care<\/em>; 17(6):515-520<br \/> (4) Vandenbranden, S.L. et al, 2012,\u00a0<em>Pediatric Pulmonology<\/em>, 2012; 47(2): 135-143<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5MzU2MyMzODQ3Njg1IzIwODIyMDc=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/3f627444-5331-4979-91c6-067ee53e86e4\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Patient screening and dosing ongoing in Turkey and Hungary Topline data expected in Q2 2021 for the Combination Trial DELRAY BEACH, Fla., Nov. 30, 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 the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). \u201cIn the midst of a global pandemic and unpredictable obstacles, we are very encouraged to see our Combination therapy trial moving forward &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency&#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-389417","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 Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency - 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-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Patient screening and dosing ongoing in Turkey and Hungary Topline data expected in Q2 2021 for the Combination Trial DELRAY BEACH, Fla., Nov. 30, 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 the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). \u201cIn the midst of a global pandemic and unpredictable obstacles, we are very encouraged to see our Combination therapy trial moving forward &hellip; Continue reading &quot;AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-30T13:03:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5MzU2MyMzODQ3Njg1IzIwODIyMDc=\" \/>\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=\"5 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-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency\",\"datePublished\":\"2020-11-30T13:03:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/\"},\"wordCount\":1057,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODA5MzU2MyMzODQ3Njg1IzIwODIyMDc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\\\/\",\"name\":\"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency - 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(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 the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). \u201cIn the midst of a global pandemic and unpredictable obstacles, we are very encouraged to see our Combination therapy trial moving forward &hellip; Continue reading \"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-30T13:03:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5MzU2MyMzODQ3Njg1IzIwODIyMDc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency","datePublished":"2020-11-30T13:03:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/"},"wordCount":1057,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5MzU2MyMzODQ3Njg1IzIwODIyMDc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/azurrx-biopharma-announces-first-patients-dosed-in-turkey-for-phase-2-combination-therapy-trial-of-ms1819-in-cystic-fibrosis-patients-with-severe-exocrine-pancreatic-insufficiency\/","name":"AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency - 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