{"id":725619,"date":"2023-01-25T07:18:15","date_gmt":"2023-01-25T12:18:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/"},"modified":"2023-01-25T07:18:15","modified_gmt":"2023-01-25T12:18:15","slug":"first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/","title":{"rendered":"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">BOCA RATON, Fla., Jan.  25, 2023  (GLOBE NEWSWIRE) &#8212; First Wave BioPharma, Inc. (NASDAQ: FWBI) (\u201cFirst Wave BioPharma\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for\u202fgastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase\u2019s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.<\/p>\n<p>Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.<\/p>\n<p>\u201cEnhancing the IP portfolio protecting adrulipase and the microgranule drug delivery formulation is an important value-building opportunity for First Wave as we prepare to soon initiate the Phase 2 clinical trial of adrulipase in exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis,\u201d said James Sapirstein, President and CEO of First Wave BioPharma. \u201cWe believe that our reformulation of adrulipase offers the potential to provide a substantially improved treatment option for EPI patients that is differentiated from therapeutics currently used to treat the condition.\u201d<\/p>\n<p>\n        <em>In vitro<\/em> data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit. Additionally, <em>in vitro<\/em> research indicates the enhanced formulation has the potential to significantly decrease the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill burden for current commercial pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, creating a substantial challenge for EPI patients.<\/p>\n<p>\n        <strong>About Adrulipase\u202f<\/strong>\u00a0<br \/>Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the <em>Yarrowia lipolytica<\/em> yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient\u2019s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge, and weight loss. 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.\u00a0\u00a0<\/p>\n<p align=\"justify\">\n        <strong>About First Wave BioPharma, Inc.<\/strong>\u00a0<br \/>First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple clinical stage programs built around its two proprietary technologies \u2013 the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). In developing adrulipase, First Wave is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. The company is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn\u2019s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=nr73YtdWQclo7FK_MqP3zyLTT9WjLJRd3p9e_U8ewZAxBfhsQg4MOaWxuHXcyUbRptkaO2ts558GP4JMH8CbTrIp1IjVHHLlekf1O_JlR-M=\" rel=\"nofollow noopener\" target=\"_blank\"><u>www.firstwavebio.com<\/u><\/a>.\u00a0<br \/>\u00a0\u00a0<br \/><strong>Forward-Looking Statement<\/strong>\u00a0<br \/><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; whether the Company will be able to regain and maintain compliance with Nasdaq\u2019s continued listing criteria; the size of the potential markets for the Company\u2019s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company\u2019s business, operating results and financial prospects; 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, 2021, 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><\/p>\n<p>\n        <strong>For more information:<\/strong>\u00a0<br \/>First Wave BioPharma, Inc.\u00a0<br \/>777 Yamato Road, Suite 502\u00a0<br \/>Boca Raton, FL 33431\u00a0<br \/>Phone: (561) 589-7020\u00a0<br \/>info@firstwavebio.com\u00a0<\/p>\n<p>Media contact:\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=DW2cTG3j-qodlRjhHGc9o4D1FDgz5aRmK4g6zBJm0HM3UY8TLQcttwo8SAzk80fxYFtOTFAAzbvIjvriHsK4LS5nwAu0URWYnQ5JuRMMO24=\" rel=\"nofollow noopener\" target=\"_blank\"><u>Tiberend Strategic Advisors, Inc.<\/u><\/a>\u00a0<br \/>David Schemelia\u00a0<br \/>(609) 468-9325\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xIgRuRYPK23R2OXy4wWWfXLfDHhmkWEBF-59farOAxh9kYQj18NVZ2PADEeVUxPd3YZsMWtr4jVgQD2L5f5UcXo7b6Qbx79MjlA9SiO5Ds0=\" rel=\"nofollow noopener\" target=\"_blank\"><u>dschemelia@tiberend.com<\/u><\/a>\u00a0<\/p>\n<p \/>\n      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTY2OCM1MzcyMDM4IzIwODIyMDc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MTc0NDQxYTUtNDRlYi00MDZhLTg1NjYtZjZlNWYxYzllMGFhLTEwOTM3Nzg=\/tiny\/First-Wave-BioPharma-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>BOCA RATON, Fla., Jan. 25, 2023 (GLOBE NEWSWIRE) &#8212; First Wave BioPharma, Inc. (NASDAQ: FWBI) (\u201cFirst Wave BioPharma\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for\u202fgastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase\u2019s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase. Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio&#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-725619","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>First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio - 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\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"BOCA RATON, Fla., Jan. 25, 2023 (GLOBE NEWSWIRE) &#8212; First Wave BioPharma, Inc. (NASDAQ: FWBI) (\u201cFirst Wave BioPharma\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for\u202fgastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase\u2019s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase. Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) &hellip; Continue reading &quot;First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-25T12:18:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTY2OCM1MzcyMDM4IzIwODIyMDc=\" \/>\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\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio\",\"datePublished\":\"2023-01-25T12:18:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/\"},\"wordCount\":994,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODczNTY2OCM1MzcyMDM4IzIwODIyMDc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\\\/\",\"name\":\"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio - 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(NASDAQ: FWBI) (\u201cFirst Wave BioPharma\u201d or the \u201cCompany\u201d), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for\u202fgastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase\u2019s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase. Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) &hellip; Continue reading \"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/","og_site_name":"Market Newsdesk","article_published_time":"2023-01-25T12:18:15+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTY2OCM1MzcyMDM4IzIwODIyMDc=","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\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio","datePublished":"2023-01-25T12:18:15+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/"},"wordCount":994,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTY2OCM1MzcyMDM4IzIwODIyMDc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-wave-biopharma-announces-expansion-of-adrulipase-intellectual-property-portfolio\/","name":"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio - 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