{"id":514423,"date":"2021-07-19T08:04:17","date_gmt":"2021-07-19T12:04:17","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\/"},"modified":"2021-07-19T08:04:17","modified_gmt":"2021-07-19T12:04:17","slug":"prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\/","title":{"rendered":"Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>-First precision approach to IBD by utilizing a companion diagnostic to identify patients-<\/em><br \/>\n        \n      <\/p>\n<p align=\"center\">\n        <em>-Phase 2a initiation in Crohn\u2019s Disease on track for 3<\/em><br \/>\n        <sup><br \/>\n          <em>rd<\/em><br \/>\n        <\/sup><br \/>\n        <em> Quarter 2021-<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>&#8211; Further details to be provided at R&amp;D Day on July 28<\/em><br \/>\n        <sup><br \/>\n          <em>th<\/em><br \/>\n        <\/sup><br \/>\n        <em>&#8211;<\/em>\n      <\/p>\n<p>SAN DIEGO, July  19, 2021  (GLOBE NEWSWIRE) &#8212; Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. The study is placebo-controlled and statistically powered to evaluate the efficacy and safety of PRA023 in UC patients.\u00a0\u00a0 The company plans to provide more details of the Phase 2 ARTEMIS-UC study at R&amp;D Day on July 28<sup>th<\/sup>.<\/p>\n<p>\u201cThe majority of patients with UC cannot achieve clinical remission through the use of currently available therapies,\u201d said Allison Luo, MD, Chief Medical Officer of Prometheus. \u201cThis gives Prometheus compelling motivation to rapidly advance PRA023, addressing both inflammation and fibrosis and leading the precision medicine approach in the IBD space, starting first with the ARTEMIS-UC study.\u201d<\/p>\n<p>Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers. Safety and tolerability observed to date supports the initiation of a Phase 2 trial. Final Phase 1a results of PRA023 in UC and CD are expected in the fourth quarter of 2021. Further details will be provided at the company\u2019s R&amp;D Day on July 28, 2021. Register here: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=0PomNIY3DWPA8B6V0FOyj4BNsxRhJlPvGNJyw_6yV1tKC5G-Yc9mM5d0Ggml4O9ihno_e6eoXtD1fwiiWWGmkS-QCxrJQxn-L-7k_kfEPk5ZdycCePl-ku0wlhsxVZmELQat3bMwHAcWDDgrhYWebu9YRnClwvjHap4giEiDXpxCaYxQV-bUnj7ngsFHYgVXiBk0Xn740ABpcAqktnxBjw==\" rel=\"nofollow noopener\" target=\"_blank\">Prometheus R&amp;D Day<\/a><\/p>\n<p>\n        <strong>About PRA023 <\/strong>\n      <\/p>\n<p>PRA023 is an IgG1 humanized monoclonal antibody (mAb) that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane-associated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for\u00a0moderate-to-severe\u00a0IBD patients predisposed to increased TL1A expression. Prometheus is developing PRA023 for the treatment of the two most common forms of IBD, Ulcerative Colitis (UC) and Crohn\u2019s Disease (CD). The Company has initiated enrollment in a Phase 2 trial in UC patients. The Company is also developing a genetic-based companion diagnostic to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.<\/p>\n<p>\n        <strong>About\u00a0Prometheus Biosciences<\/strong>\n      <\/p>\n<p>Prometheus Biosciences, Inc. is a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of immune-mediated diseases, starting first with IBD. The Company\u2019s\u00a0precision medicine platform, Prometheus360\u2122, combines proprietary bioinformatics discovery methods with one of the world\u2019s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.\u00a0 Prometheus is headquartered in San Diego, CA.<\/p>\n<p>\n        <strong>Forward Looking Statements<\/strong>\n      <\/p>\n<p>Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company\u2019s current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the timing of commencement of Prometheus\u2019 Phase 2 clinical trial in UC and its Phase 2a clinical trial in CD; Prometheus\u2019 Enroll360\u2122 program and the company\u2019s ability to accelerate enrollment in its planned and other future clinical trials; and the timing of Prometheus obtaining the final study results from its Phase 1a clinical trial of PRA023. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: Prometheus\u2019 approach to the discovery and development of precision medicines based on Prometheus360\u2122 is unproven; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; Prometheus\u2019 dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus\u2019 ability to develop companion diagnostics for our therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and\/or commercialization, or may result in recalls or product liability claims; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; Prometheus may not realize any benefits from our current and any future collaborations; regulatory developments in\u00a0the United States\u00a0and foreign countries; Prometheus\u2019 ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; Prometheus\u2019 ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain;\u00a0and other risks described in the company\u2019s prior press releases and filings with the\u00a0Securities and Exchange Commission\u00a0(SEC), including under the heading \u201cRisk Factors\u201d in Prometheus\u2019 most recent quarterly report on Form 10-Q and any subsequent filings with the\u00a0SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.<\/p>\n<p>\n        <strong>Contacts:<\/strong><br \/>\n        <br \/>Noel Kurdi<br \/>VP Investor Relations and Communications<br \/>(646) 241-4400<br \/>nkurdi@prometheusbiosciences.com<\/p>\n<p>\n        <strong>Media contact:<br \/><\/strong>Juniper Point<br \/>Amy Conrad<br \/>(858) 914-1962<br \/>media@prometheusbiosciences.com<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI4MjA1OSM0MzAxNjA2IzIyMDgxOTk=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/61279ec1-d875-4473-82e6-a8c5a32f2a30\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>-First precision approach to IBD by utilizing a companion diagnostic to identify patients- -Phase 2a initiation in Crohn\u2019s Disease on track for 3 rd Quarter 2021- &#8211; Further details to be provided at R&amp;D Day on July 28 th &#8211; SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) &#8212; Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. The study is placebo-controlled and statistically powered to evaluate the efficacy &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)&#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-514423","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>Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC) - 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\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"-First precision approach to IBD by utilizing a companion diagnostic to identify patients- -Phase 2a initiation in Crohn\u2019s Disease on track for 3 rd Quarter 2021- &#8211; Further details to be provided at R&amp;D Day on July 28 th &#8211; SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) &#8212; Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. The study is placebo-controlled and statistically powered to evaluate the efficacy &hellip; Continue reading &quot;Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-19T12:04:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI4MjA1OSM0MzAxNjA2IzIyMDgxOTk=\" \/>\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\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)\",\"datePublished\":\"2021-07-19T12:04:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/\"},\"wordCount\":958,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODI4MjA1OSM0MzAxNjA2IzIyMDgxOTk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/prometheus-biosciences-announces-initiation-of-global-phase-2-clinical-trial-of-pra023-in-moderate-to-severe-ulcerative-colitis-uc\\\/\",\"name\":\"Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC) - 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(Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. 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