{"id":7416,"date":"2018-11-14T14:50:28","date_gmt":"2018-11-14T14:50:28","guid":{"rendered":"https:\/\/laforcedmd.com\/?p=7416"},"modified":"2022-05-03T18:14:11","modified_gmt":"2022-05-03T18:14:11","slug":"polaris-dmd-phase-3-trial-edasalonexent","status":"publish","type":"post","link":"https:\/\/laforcedmd.com\/en\/polaris-dmd-phase-3-trial-edasalonexent\/","title":{"rendered":"POLARIS DMD, a phase 3 trial on edasalonexent"},"content":{"rendered":"<p><strong>One of the objectives of our team is to inform you about new treatments. Here&#8217;s the latest news about Polaris DMD, the clinical trial of edasalonexent, developed by Catabasis. Thank you for sharing these articles in the DMD community.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>Maria Mancini, vice president of clinical operations at Catabasis:<\/strong>\u00a0We named the trial \u2018Polaris\u2019 because it is the brightest star in its constellation and it\u2019s also known as the North Star.<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3>What is Polaris DMD?<\/h3>\n<p>Polaris DMD is a phase 3 trial of edasalonexent, a potential treatment for Duchenne muscular dystrophy (DMD), regardless of mutation type, is enrolling boys ages 4 to 7 in the U.S. Registration information is available here &gt;<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03703882?term=edasalonexent&amp;cond=Duchenne+Muscular+Dystrophy&amp;rank=1\" rel=\"noopener\"> Clinicaltrials.gov<\/a>.<\/p>\n<p>The Polaris DMD Trial is a one-year, randomized, placebo-controlled trial. Catabasis began evaluating patients on October 2 at several sites in the United States. Catabasis plans to conduct the trial at nearly 40 sites around the world. The results are expected in June 2020.<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis:<\/strong> We are very excited to advance edasalonexent through this potentially last phase of clinical development with the hope of providing a new treatment option to all boys affected by this disease. We believe that edasalonexent has great potential as a therapy to be taken on its own as well as in combination with other treatments.<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3>What is Edasalonexent?<\/h3>\n<p>Edasalonexent (CAT-1004) \u00a0is being developed as a potential foundational disease-modifying therapy for all patients affected by DMD, regardless of their underlying mutation. It is an investigational oral small molecule. Edasalonexent inhibits NF-kB, a protein that is activated by DMD and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration.<\/p>\n<p>&nbsp;<\/p>\n<h3>Positive results<\/h3>\n<p>Statistically, significant improvement was observed compared to the off-treatment control period. These improvements show a slowing of disease progression and are in addition to the improvements found in all assessments of muscle function through more than a year of edasalonexent treatment.<\/p>\n<p>&nbsp;<\/p>\n<h3>About DMD<\/h3>\n<p>Duchenne muscular dystrophy (DMD) is a disease that almost exclusively affects boys and whose incidence is 1 in 3,500. It is extremely rare that Duchenne muscular dystrophy (DMD) will affect girls. Those affected are usually diagnosed around the age of five, but symptoms may be visible from early childhood. It is a degenerative disease of the muscles caused by a genetic mutation. The Duchenne muscular dystrophy (DMD) \u2013 for which no treatment is currently available \u2013 directly affects skeletal muscles. Without treatment, the consequences of the disease are dire for those afflicted and their families.<\/p>\n<p>&nbsp;<\/p>\n<h3>For more information<\/h3>\n<p>More information about Catabasis:\u00a0<a href=\"http:\/\/www.catabasis.com\" rel=\"noopener\">www.catabasis.com<\/a><\/p>\n<p>More:\u00a0<a href=\"\/?p=5080\" rel=\"noopener\">Portrait of Duchenne \u2013 edasalonexent cat-1004 \u2013 La Force DMD<\/a><\/p>\n<p>Muscular Dystrophy News:\u00a0<a href=\"https:\/\/musculardystrophynews.com\/2018\/11\/12\/phase-3-trial-of-edasalonexent-in-boys-with-dmd-and-any-mutation-enrolling-in-us-catabasis-reports\/\" rel=\"noopener\">www.musculardystrophynews.com<\/a><\/p>\n<p>More information about the Polaris DMD trial: <a href=\"https:\/\/www.catabasis.com\/patients-families\/polaris-dmd-clinical-trial.php\" rel=\"noopener\">Catabasis \u2013 Polaris DMD<\/a><\/p>\n<p>Business Wire:\u00a0<a href=\"https:\/\/www.businesswire.com\/news\/home\/20180709005089\/en\/Catabasis-Pharmaceuticals-Announces-Plans-Edasalonexent-Phase-3\" rel=\"noopener\">www.businesswire.com<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>One of the objectives of our team is to inform you about new treatments. Here&#8217;s the latest news about Polaris DMD, the clinical trial of edasalonexent, developed by Catabasis. Thank you for sharing these articles in the DMD community. &nbsp; Maria Mancini, vice president of clinical operations at Catabasis:\u00a0We named the trial \u2018Polaris\u2019 because it [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7417,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-7416","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-research"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>POLARIS DMD, a phase 3 trial on edasalonexent<\/title>\n<meta name=\"description\" content=\"Polaris DMD, a phase 3 trial of edasalonexent, a potential treatment for Duchenne muscular dystrophy developed by Catabasis.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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