AzurRx's Stock Falls After MS1819 For Pancreatic Insufficiency Flunks Mid-Stage Study

Benzinga

2021-04-01

AzurRx BioPharma Inc (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 trial evaluating MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency.
MS1819 demonstrated to be safe and well-tolerated. However, the study did not consistently meet the primary efficacy endpoint.
Some patients achieved a coefficient of fat absorption (CFA) at levels beyond what is required to demonstrate non-inferiority with porcine enzyme replacement therapy (PERT) therapies, but the majority did not.
The company believes that the leading cause of the drug's uneven efficacy performance lies with the enteric capsule formulation.
While the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme for proper digestion and nutrient absorption.
The company is planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON, ZENPEP, and other PERT therapies.
MS1819 is a recombinant lipase enzyme for treating exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.
Price Action: AZRX shares dropped 23.9% at $0.988 in the premarket session on the last check Thursday.

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However, the study did not consistently meet the primary efficacy endpoint.</li>\n<li>Some patients achieved a coefficient of fat absorption (CFA) at levels beyond what is required to demonstrate non-inferiority with porcine enzyme replacement therapy (PERT) therapies, but the majority did not.</li>\n<li>The company believes that the leading cause of the drug's uneven efficacy performance lies with the enteric capsule formulation.</li>\n<li>While the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme for proper digestion and nutrient absorption.</li>\n<li>The company is planning to pursue a new formulation for MS1819, this <a href=\"https://laohu8.com/S/AONE\">one</a> a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON, ZENPEP, and other PERT therapies.</li>\n<li>MS1819 is a recombinant lipase enzyme for treating exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.</li>\n<li><strong>Price Action:</strong> AZRX shares dropped 23.9% at $0.988 in the premarket session on the last check Thursday.</li>\n</ul>\n<p><strong>See more from Benzinga</strong></p>\n<ul>\n<li>Click here for options trades from Benzinga</li>\n<li>BioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study</li>\n<li>15M Doses Of JNJ COVID-19 Vaccine Batch Ruined After Ingredient Issues At <a href=\"https://laohu8.com/S/EBS\">Emergent Biosolutions</a>' US Plant: NYT</li>\n</ul>\n<p><i>© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.</i></p></body></html>","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>AzurRx's Stock Falls After MS1819 For Pancreatic Insufficiency Flunks Mid-Stage Study</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nAzurRx's Stock Falls After MS1819 For Pancreatic Insufficiency Flunks Mid-Stage Study\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-04-01 18:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/azurrxs-stock-falls-ms1819-pancreatic-103044978.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>AzurRx BioPharma Inc (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 trial evaluating MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency.\nMS1819 demonstrated ...</p>\n\n<a href=\"https://finance.yahoo.com/news/azurrxs-stock-falls-ms1819-pancreatic-103044978.html\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":null,"symbol_name":null,"start_time":0,"source_url":"https://finance.yahoo.com/news/azurrxs-stock-falls-ms1819-pancreatic-103044978.html","article_id":"2124078437","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/3ftOn8OtTEOHyElVVNcvXQ--~B/aD00MDA7dz02MDA7YXBwaWQ9eXRhY2h5b24-/https://s.yimg.com/uu/api/res/1.2/1_sYaPbArqkNgugGXGLzAg--~B/aD00MDA7dz02MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/b1cf0ab80b3e00627f755b0e39f386e6"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2124078437","pubTimestamp":1617273044,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"AzurRx BioPharma Inc (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 trial evalua","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"MS1819治疗胰腺功能不全的中期研究失败后Azurrx的股票下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AZRX":0.9},"content_text":"AzurRx BioPharma Inc (NASDAQ: AZRX) reported topline results from its Phase 2b OPTION 2 trial evaluating MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency.\nMS1819 demonstrated to be safe and well-tolerated. However, the study did not consistently meet the primary efficacy endpoint.\nSome patients achieved a coefficient of fat absorption (CFA) at levels beyond what is required to demonstrate non-inferiority with porcine enzyme replacement therapy (PERT) therapies, but the majority did not.\nThe company believes that the leading cause of the drug's uneven efficacy performance lies with the enteric capsule formulation.\nWhile the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme for proper digestion and nutrient absorption.\nThe company is planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON, ZENPEP, and other PERT therapies.\nMS1819 is a recombinant lipase enzyme for treating exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.\nPrice Action: AZRX shares dropped 23.9% at $0.988 in the premarket session on the last check Thursday.\n\nSee more from Benzinga\n\nClick here for options trades from Benzinga\nBioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study\n15M Doses Of JNJ COVID-19 Vaccine Batch Ruined After Ingredient Issues At Emergent Biosolutions' US Plant: NYT\n\n© 2021 Benzinga.com. 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