{"id":1680,"date":"2025-09-17T13:08:02","date_gmt":"2025-09-17T13:08:02","guid":{"rendered":"https:\/\/admarebio.com\/news-events\/news-insights\/"},"modified":"2026-06-26T18:42:49","modified_gmt":"2026-06-26T18:42:49","slug":"thryv-therapeutics-announces-fda-ind-clearance-of-thrv-1268-for-long-qt-syndrome","status":"publish","type":"post","link":"https:\/\/admarebio.com\/news-events\/news-insights\/thryv-therapeutics-announces-fda-ind-clearance-of-thrv-1268-for-long-qt-syndrome\/","title":{"rendered":"Thryv Therapeutics Announces FDA IND Clearance of THRV-1268 for Long QT Syndrome"},"content":{"rendered":"\n<p><strong>Montreal, Quebec \u2013 September 17, 2025&nbsp;<\/strong>\u2013 Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead compound, THRV-1268. This clearance enables Thryv to initiate the Phase 2\/3 WAVE II clinical study in Long QT Syndrome (LQTS) Type 2.&nbsp;<\/p>\n\n\n\n<p><strong>Details of the Phase 2\/3 WAVE II Clinical Study<\/strong>&nbsp;<\/p>\n\n\n\n<p>The Phase 2\/3 Wave II study will evaluate the safety and efficacy of THRV-1268 in patients with LQTS Type 2. The primary endpoint is the mean change from baseline in area under the curve corrected QT interval (QTc AUC (0-6)\/6) over six weeks of treatment in adult patients with a baseline QTc &gt;480 milliseconds, regardless of background beta-blocker therapy.&nbsp;<\/p>\n\n\n\n<p>In parallel with this regulatory milestone, Thryv secured new financing to initiate the Wave II clinical study, marking a significant advancement for THRV-1268 and reflecting strong confidence in Thryv\u2019s differentiated science and leadership in SGK1 inhibition. Thryv\u2019s investors bring deep expertise in cardiovascular development, digital health integration, and global commercialization\u2014providing the capital strength to accelerate THRV-1268 through registrational studies. The financing was supported by Amplitude Ventures, Fonds de solidarit\u00e9 FTQ, Lumira Ventures, Investissement Qu\u00e9bec, adMare BioInnovations, and CTI Life Sciences Fund.&nbsp;<\/p>\n\n\n\n<p><strong>Building on Recent Regulatory Momentum<\/strong>&nbsp;<\/p>\n\n\n\n<p>This is the second IND clearance for Thryv in recent months, following FDA acceptance of an IND for THRV-1268 in heart failure and atrial fibrillation. Together, these regulatory achievements highlight the broad therapeutic potential of SGK1 inhibition across multiple serious cardiovascular diseases.&nbsp;<\/p>\n\n\n\n<p>Thryv\u2019s extensive work with its first compound, LQT-1213, provided foundational non-clinical and clinical evidence supporting SGK1 inhibition in LQTS. Building on that success, THRV-1268 is being advanced as a best-in-class, optimized SGK1 inhibitor for LQTS, designed for long-term therapy in this chronic, life-threatening disease.&nbsp;<\/p>\n\n\n\n<p>\u201cThis FDA clearance and the launch of the Wave II Phase 2\/3 study early next year represent major milestones in the development of what could become the first approved therapy for Long QT Syndrome,\u201d said Paul Truex, Chairman and CEO of Thryv Therapeutics. \u201cWith strong investor support, Thryv is positioned to move rapidly into registration studies. Adults and children with LQTS deserve therapies that not only protect their lives but also allow them to live more fully\u2014we are determined to deliver on that promise.\u201d&nbsp;<\/p>\n\n\n\n<p><strong>About Long QT Syndrome<\/strong>&nbsp;<\/p>\n\n\n\n<p>Long QT Syndrome (LQTS) is a rare inherited cardiac arrhythmia condition characterized by delayed ventricular repolarization, reflected on the electrocardiogram (ECG) as a prolonged QT interval. Prolongation of the QT interval increases the risk of torsades de pointes, a potentially life-threatening ventricular tachyarrhythmia. Individuals with LQTS are at greatest risk of arrhythmic events in response to physiological stressors such as exercise or emotional stress.&nbsp;<\/p>\n\n\n\n<p>The three most common subtypes of congenital LQTS are Type 1, Type 2, and Type 3, each caused by distinct ion channel gene mutations that influence the specific triggers for arrhythmic events. In addition to the congenital forms, LQTS may also be acquired, most often due to exposure to medications that prolong the QT interval and similarly increase the risk of sudden cardiac death.&nbsp;<\/p>\n\n\n\n<p><strong>About Thryv Therapeutics&nbsp;Inc.<\/strong><\/p>\n\n\n\n<p>Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat Long QT Syndrome, heart failure and atrial fibrillation with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK-1).&nbsp;For more information, please visit www.thryvtrx.com.&nbsp;<\/p>\n\n\n\n<p><strong>Media Inquiries<\/strong><\/p>\n\n\n\n<p><a href=\"mailto:brittany@thryvtrx.com\">brittany@thryvtrx.com<\/a>&nbsp;| 514 973 0915<\/p>\n\n\n\n<p><a href=\"https:\/\/thryvtrx.com\/news\/lqts-ind-1268\">Read the original press release here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Montreal, Quebec \u2013 September 17, 2025&nbsp;\u2013 Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced that the U.S. [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":1620,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[29],"tags":[],"company":[18],"class_list":["post-1680","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-portfolio-companies"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Thryv Therapeutics Announces FDA IND Clearance of THRV-1268 for Long QT Syndrome | adMare<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Thryv Therapeutics Announces FDA IND Clearance of THRV-1268 for Long QT Syndrome | adMare\" \/>\n<meta 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