{"id":62953,"date":"2026-04-17T01:03:12","date_gmt":"2026-04-16T23:03:12","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/khondrion-announces-first-patient-dosed-in-pivotal-phase-3-khenerfin-study-of-sonlicromanol-in-mitochondrial-dna-3243ag-primary-mitochondrial-disease\/"},"modified":"2026-04-17T01:03:12","modified_gmt":"2026-04-16T23:03:12","slug":"khondrion-announces-first-patient-dosed-in-pivotal-phase-3-khenerfin-study-of-sonlicromanol-in-mitochondrial-dna-3243ag-primary-mitochondrial-disease","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/khondrion-announces-first-patient-dosed-in-pivotal-phase-3-khenerfin-study-of-sonlicromanol-in-mitochondrial-dna-3243ag-primary-mitochondrial-disease\/","title":{"rendered":"Khondrion Announces First Patient Dosed in Pivotal Phase 3 KHENERFIN Study of Sonlicromanol in Mitochondrial DNA 3243A&gt;G Primary Mitochondrial Disease"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>52-week Phase 3 trial evaluating the efficacy and safety of sonlicromanol, a novel brain-penetrant redox-modulator with anti-ferroptotic and anti-inflammatory properties, in adult patients with the most common genetic defect causing primary mitochondrial disease, m.3243A&gt;G<\/i><\/li>\n<li>\n<i>Primary endpoints focus on most bothersome and frequently occurring effects of disease \u2013 chronic fatigue and muscle weakness \u2013 supported by consistent signals observed in Phase 2b program<\/i><\/li>\n<\/ul>\n<p>NIJMEGEN, The Netherlands&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/Phase3?src=hash\" target=\"_blank\">#Phase3<\/a>&#8211;Khondrion today announced that the first patient has been dosed in the pivotal, randomized, placebo-controlled Phase 3 <i>KHENERFIN<\/i> study (NCT 06451757) evaluating the efficacy and safety of sonlicromanol, its investigational small molecule for m.3243A&gt;G-related Primary Mitochondrial Disease.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260416950368\/en\/2777223\/5\/khondrion-logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260416950368\/en\/2777223\/22\/khondrion-logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260416950368\/en\/2777223\/5\/khondrion-logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260416950368\/en\/2777223\/21\/khondrion-logo.jpg\"><\/a><\/p>\n<p>\n&#8220;The initiation of patient dosing in our Phase 3 KHENERFIN study marks an important milestone in the development of a potential treatment for patients with m.3243A&gt;G primary mitochondrial disease,\u201d said Jasper Levink, CEO of Khondrion. \u201cThis trial is designed to rigorously evaluate the safety and efficacy of sonlicromanol in a larger, randomized setting, with endpoints reflecting key aspects of disease burden, building on the signals observed in our earlier clinical program.\u201d<\/p>\n<p>\nDr. Mirian Jansen, head of the clinical metabolic department of the Radboudumc and PI in the KHENERFIN study noted: \u201cm.3243A&gt;G Primary Mitochondrial Disease is a progressive and debilitating condition with significant unmet medical need, affecting patients across multiple organ systems and often leading to increasing disability over time. As investigators, we are committed to advancing this Phase 3 study and working closely with patients to ensure high-quality data collection on outcomes that matter in daily life. This trial is designed to determine whether this investigational therapy can meaningfully impact patient function and fatigue.\u201d<\/p>\n<p>\n\u201cThe most burdensome symptoms m.3243A&gt;G patients experience are fatigue and muscle weakness. These symptoms are often debilitating and impact every area of life. The initiation of the Phase 3 <i>KHENERFIN<\/i> study by Khondrion is a significant achievement and provides hope to the international mitochondrial disease community. As the Chair of International Mito Patients (IMP), which represents 25 mitochondrial disease patient advocacy groups across five continents, we are encouraged by the progress being made in research and drug development for those living with Primary Mitochondrial Diseases. We optimistically await the outcome of the trial,\u201d stated Paula Morandi, Chair of IMP.<\/p>\n<p>\nJan Smeitink, Khondrion\u2019s founder and CMO continued: \u201cThe KHENERFIN study will enroll up to 220 adult patients from 18 years and older across Europe, the United Kingdom and the US with genetically confirmed m.3243A&gt;G Primary Mitochondrial Disease. Participants will be randomized 1:1 to receive sonlicromanol or placebo over a 52-week treatment period. Participants will receive 90 mg sonlicromanol or matching placebo as dispersible tablets twice daily. The study\u2019s two independent primary endpoints are change in NeuroQoL Fatigue Short Form score and performance on the 5-times sit-to-stand test, reflecting key aspects of disease burden.\u201d<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<a target=\"_blank\" href=\"mail&#116;&#111;&#58;&#105;&#110;&#102;&#111;&#x40;&#x6b;&#x68;&#x6f;&#x6e;&#x64;&#x72;&#x69;&#x6f;n&#46;co&#109;\" rel=\"nofollow\" shape=\"rect\">&#x69;&#110;&#x66;&#111;&#64;&#x6b;&#104;o&#x6e;&#100;&#x72;&#x69;o&#x6e;&#46;c&#x6f;&#109;<\/a><br \/>+31 (0)24 763 50 00<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>52-week Phase 3 trial evaluating the efficacy and safety of sonlicromanol, a novel brain-penetrant redox-modulator with anti-ferroptotic and anti-inflammatory properties, in adult patients with the most common genetic defect causing primary mitochondrial disease, m.3243A&gt;G Primary endpoints focus on most bothersome and frequently occurring effects of disease \u2013 chronic fatigue and muscle weakness \u2013 supported by &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/khondrion-announces-first-patient-dosed-in-pivotal-phase-3-khenerfin-study-of-sonlicromanol-in-mitochondrial-dna-3243ag-primary-mitochondrial-disease\/\">[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-62953","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>Khondrion Announces First Patient Dosed in Pivotal Phase 3 KHENERFIN Study of Sonlicromanol in Mitochondrial DNA 3243A&gt;G Primary Mitochondrial Disease - 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\/khondrion-announces-first-patient-dosed-in-pivotal-phase-3-khenerfin-study-of-sonlicromanol-in-mitochondrial-dna-3243ag-primary-mitochondrial-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Khondrion Announces First Patient Dosed in Pivotal Phase 3 KHENERFIN Study of Sonlicromanol in Mitochondrial DNA 3243A&gt;G Primary Mitochondrial Disease - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"52-week Phase 3 trial evaluating the efficacy and safety of sonlicromanol, a novel brain-penetrant redox-modulator with anti-ferroptotic and anti-inflammatory properties, in adult patients with the most common genetic defect causing primary mitochondrial disease, m.3243A&gt;G Primary endpoints focus on most bothersome and frequently occurring effects of disease \u2013 chronic fatigue and muscle weakness \u2013 supported by ... 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