{"id":61204,"date":"2025-05-06T01:06:47","date_gmt":"2025-05-05T23:06:47","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/thetis-pharmaceuticals-presents-new-preclinical-and-clinical-data-fortp-317-at-ddw-2025\/"},"modified":"2025-05-06T01:06:47","modified_gmt":"2025-05-05T23:06:47","slug":"thetis-pharmaceuticals-presents-new-preclinical-and-clinical-data-fortp-317-at-ddw-2025","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/thetis-pharmaceuticals-presents-new-preclinical-and-clinical-data-fortp-317-at-ddw-2025\/","title":{"rendered":"Thetis Pharmaceuticals Presents New Preclinical and Clinical Data forTP-317 at DDW 2025"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>Findings Highlight First-in-Class Potential of TP-317 in Inflammatory Bowel Disease and Colorectal Cancer<\/i>\n<\/p>\n<p>ESSEX, Conn.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/IBD?src=hash\" target=\"_blank\">#IBD<\/a>&#8211;Thetis Pharmaceuticals LLC (\u201cThetis\u201d), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and solid tumor cancers, today announced the presentation of four data sets at Digestive Disease Week (DDW) 2025, held May 3-6 in San Diego, California. The data support TP-317\u2019s advancement as a novel oral therapy for both IBD and microsatellite stable (MSS) colorectal cancer (CRC).\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250505954671\/en\/2459189\/5\/Thetis-logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250505954671\/en\/2459189\/22\/Thetis-logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250505954671\/en\/2459189\/5\/Thetis-logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250505954671\/en\/2459189\/21\/Thetis-logo.jpg\"><\/a><\/p>\n<p>\n\u201cThese data show how TP-317 can meaningfully impact immune-mediated diseases by activating the BLT1 pathway. In IBD, TP-317 promotes epithelial repair and resolves mucosal inflammation. In solid tumors, TP-317 promotes antigen presentation to enhance the efficacy of immune checkpoint inhibitors in tumors that are resistant to immunotherapy,\u201d said Gary Mathias, CEO of Thetis Pharmaceuticals. \u201cWith encouraging preclinical results in IBD and MSS colorectal cancer and positive safety and PK\/PD data from our Phase 1a study, TP-317 is well-positioned for Phase 2 clinical development in both indications.\u201d\n<\/p>\n<p>\n<b>Colorectal Cancer: Immune Reprogramming and Combination Potential<\/b>\n<\/p>\n<p>\nIn the oral presentation<b>, \u201c<\/b><i>TP-317, an Oral BLT1 Agonist, Enhances Immune Checkpoint Inhibitor Therapy by Stimulating Tumor Antigen Presentation in a Microsatellite Stable (MSS) Tumor Model of Colorectal Cancer (CRC),<\/i><b>\u201d<\/b> TP-317 demonstrated potent anti-tumor activity and synergy with checkpoint inhibitors. Key findings include:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nTP-317 activated STING and IFN-\u03b3 pathways and boosted antigen presentation, converting immunologically \u201ccold\u201d MSS tumors into \u201chot,\u201d immune-responsive ones.\n<\/li>\n<li>\nTP-317 demonstrated robust single-agent efficacy and enhanced activity in combination with chemotherapy and checkpoint inhibitors in MSS CRC models.\n<\/li>\n<li>\nTumor control was BLT1-dependent, with broad innate and adaptive immune activation.\n<\/li>\n<\/ul>\n<p>\n<b>IBD: Barrier Protection and Mucosal Homeostasis<\/b>\n<\/p>\n<p>\nIn a second oral presentation, \u201c<i>TP-317, a Novel BLT1 Agonist Oral Therapy for IBD, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNF<sup>\u0394ARE<\/sup> Ileitis<\/i>,\u201d data from multiple colitis models showed TP-317 restored epithelial barrier function and reduced inflammation. Key findings include:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn DSS colitis, TP-317 significantly reduced disease activity, histologic inflammation, and crypt damage, demonstrating strong anti-inflammatory and mucosal barrier-protective effects on par with a JAK inhibitor and cyclosporine.\n<\/li>\n<li>\nIn TNF<sup>\u0394ARE<\/sup> ileitis, TP-317 lowered intestinal permeability and inflammatory cytokines, reinforcing its potential as a disease-modifying therapy for Crohn\u2019s disease and ulcerative colitis.\n<\/li>\n<\/ul>\n<p>\n<b>Clinical Safety and PK\/PD Profile<\/b>\n<\/p>\n<p>\nIn the poster presentation,<b> <\/b>\u201c<i>PK\/PD, Safety, and Efficacy of Oral Resolvin E1-based Therapy in IBD: Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers,\u201d <\/i>data from a Phase 1a study confirmed TP-317\u2019s safety and target engagement:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSingle oral doses up to 80 mg were well tolerated with no treatment-related adverse events.\n<\/li>\n<li>\nResolvin E1 (RvE1) exposure was dose-proportional and exceeded the EC50 for BLT1 activation.\n<\/li>\n<li>\nTransient neutrophil margination that reversed within two hours (a known pharmacodynamic effect of RvE1 at BLT1) was observed at the 80 mg dose in all subjects, indicating target engagement.\n<\/li>\n<\/ul>\n<p>\n<b>Inflammation and Pain Biomarkers Modulation<\/b>\n<\/p>\n<p>\nA second poster presentation, <i>\u201cTP-317, an Oral BLT1 Agonist, Reduces Abdominal Pain to Colorectal Distension and Reduces Key Biomarkers of Colitis in a Mouse Model of Inflammatory Bowel Disease,\u201d<\/i> further demonstrated TP-317\u2019s dual efficacy:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSignificantly reduced visceral pain responses in DNBS colitis mice.\n<\/li>\n<li>\nBroad transcriptomic suppression of genes associated with inflammation, epithelial-to-mesenchymal transition (EMT), and enteric nervous system signaling.\n<\/li>\n<li>\nCompared favorably to prednisolone across visceral pain endpoints and modulation of gene expression pathways.\n<\/li>\n<\/ul>\n<p>\nThese findings build a compelling case for TP-317 as a Phase 2-ready candidate with broad potential to address unmet needs in IBD.\n<\/p>\n<p>\n<b>About Thetis Pharmaceuticals<\/b>\n<\/p>\n<p>\nThetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral Resolvin E1 drug candidate that targets the LTB4-BLT1 pathway to mobilize the body\u2019s natural ability to resolve disease and restore immune homeostasis. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.thetispharma.com%2F&amp;esheet=54249212&amp;newsitemid=20250505954671&amp;lan=en-US&amp;anchor=www.thetispharma.com&amp;index=1&amp;md5=0dc28eabde49c2a3478741e1bfdf994b\" rel=\"nofollow\" shape=\"rect\">www.thetispharma.com<\/a>, and follow us on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fthetis-pharmaceuticals-llc%2F&amp;esheet=54249212&amp;newsitemid=20250505954671&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=1f7ad0747820bc0e1aac3739f1614de3\" rel=\"nofollow\" shape=\"rect\">LinkedIn<\/a>.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nTracy Lessor<br \/>\n<br \/>SVP, Communications<br \/>\n<br \/>Thetis Pharma<br \/>\n<br \/>617-519-9827<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#105;&#x6c;&#x74;o&#58;&#116;&#x72;&#x61;&#x63;y&#64;&#116;&#x6c;&#x6f;wc&#111;&#x6d;&#x6d;&#x75;n&#105;&#99;&#x61;&#x74;io&#110;&#x73;&#x2e;&#x63;o&#109;\" rel=\"nofollow\" shape=\"rect\">&#x74;&#x72;&#x61;&#x63;&#x79;&#64;&#116;&#108;&#111;wco&#x6d;&#x6d;&#x75;&#x6e;&#x69;&#x63;&#97;&#116;&#105;ons&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Findings Highlight First-in-Class Potential of TP-317 in Inflammatory Bowel Disease and Colorectal Cancer ESSEX, Conn.&#8211;(BUSINESS WIRE)&#8211;#IBD&#8211;Thetis Pharmaceuticals LLC (\u201cThetis\u201d), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and solid tumor cancers, today announced the presentation of four data sets at Digestive Disease &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/thetis-pharmaceuticals-presents-new-preclinical-and-clinical-data-fortp-317-at-ddw-2025\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61204","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Thetis Pharmaceuticals Presents New Preclinical and Clinical Data forTP-317 at DDW 2025 - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/thetis-pharmaceuticals-presents-new-preclinical-and-clinical-data-fortp-317-at-ddw-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Thetis Pharmaceuticals Presents New Preclinical and Clinical Data forTP-317 at DDW 2025 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Findings Highlight First-in-Class Potential of TP-317 in Inflammatory Bowel Disease and Colorectal Cancer ESSEX, Conn.&#8211;(BUSINESS WIRE)&#8211;#IBD&#8211;Thetis Pharmaceuticals LLC (\u201cThetis\u201d), a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and solid tumor cancers, today announced the presentation of four data sets at Digestive Disease ... 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