{"id":11858,"date":"2021-03-12T13:21:17","date_gmt":"2021-03-12T11:21:17","guid":{"rendered":"http:\/\/161.116.26.48\/?p=11858"},"modified":"2021-03-12T13:21:17","modified_gmt":"2021-03-12T11:21:17","slug":"accure-therapeutics-enrols-first-patient-in-the-phase-ii-clinical-trial-acute-optic-neuritis-with-its-lead-candidate-act-01","status":"publish","type":"post","link":"https:\/\/www.fbg.ub.edu\/en\/news\/accure-therapeutics-enrols-first-patient-in-the-phase-ii-clinical-trial-acute-optic-neuritis-with-its-lead-candidate-act-01\/","title":{"rendered":"Accure Therapeutics enrols first patient in the phase II clinical trial on acute optic neuritis with its lead candidate ACT-01"},"content":{"rendered":"<p><a href=\"https:\/\/www.pcb.ub.edu\/en\/empresa\/accure-therapeutics\/\" target=\"_blank\" rel=\"noopener noreferrer\">Accure Therapeutics<\/a>, a private translational R&amp;D engine at clinical stage in the Central Nervous System (CNS) field, has announced the enrollment of the first patient in\u00a0<a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04762017\" target=\"_blank\" rel=\"noopener noreferrer\">ACUITY phase II clinical trial<\/a>\u00a0on acute optic neuritis with its lead candidate ACT-01. The biotechnological company, based in the Barcelona Science Park and boosted by the\u00a0<a href=\"http:\/\/fundaciongaem.org\/en\/innovation\/\" target=\"_blank\" rel=\"noopener noreferrer\">Accelerator Programme\u00a0<\/a>of\u00a0<a href=\"https:\/\/www.pcb.ub.edu\/en\/empresa\/fundacio-grup-dafectats-desclerosi-multiple-gaem\/\" target=\"_blank\" rel=\"noopener noreferrer\">GAEM Foundation<\/a>, expects results in the second half of 2022.<\/p>\n<p>The ACUITY study is carried out within the neurology-opthalmology network of the Assistance Publique-H\u00f4pitaux de Paris (<a href=\"https:\/\/www.aphp.fr\/\">AP-HP<\/a>), with the leading site at\u00a0<a href=\"http:\/\/pitiesalpetriere.aphp.fr\/\">H\u00f4pital Pitie-Salp\u00eatri\u00e8re<\/a>. The trial is under the supervision of lead investigator Dr. C\u00e9line Louapre, from the Institut du Cerveau et de la Moelle \u00e9pini\u00e8re (<a href=\"https:\/\/institutducerveau-icm.org\/fr\/\">Institut du Cerveau \u2013 ICM<\/a>), and scientific advisor Dr. Sophie Bonnin, from the Piti\u00e9-Salp\u00e9tri\u00e8re.<\/p>\n<p>\u201cThis study is set to confirm the safety and tolerability of Accure\u2019s candidate and to provide preliminary proof-of-efficacy \u2013 both as clinical and imaging evidenced by optical coherence tomography (OCT) \u2013 of ACT-01 in patients living with inflammatory demyelinating diseases such as acute optic neuritis,\u201d said Dr. Celine Louapre. \u201cThese first efficacy results in patients will give us an estimate of the treatment effect and help us calculate the adequate sample size for the next clinical study.\u201d<\/p>\n<p>Preliminary efficacy of ACT-01 will be assessed over a six month period \u2013 post onset of AON symptoms. By this time, almost all subjects are expected to have come to the end of \u00a0their natural recovery; therefore this strategic timeline is used to compare the profiles of disease progression, and structural and functional outcomes between subjects in each treatment arm. For the majority of patients, thinning of the retinal layers in the affected eye occurs within the first six months of the onset of AON, as measured by the RNFL- retinal nerve fiber layer and the GCIPL \u2013 ganglion cell-inner plexiform layer, in an OCT scan.<\/p>\n<p><a href=\"https:\/\/www.pcb.ub.edu\/en\/accure-therapeutics-recluta-al-primer-paciente-para-el-ensayo-clinico-en-fase-ii-de-su-tratamiento-para-la-neuritis-optica-aguda\/\" target=\"_blank\" rel=\"noopener\">More information<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Accure Therapeutics, a private translational R&amp;D engine at clinical stage in the Central Nervous System (CNS) field, has announced the&#8230;<\/p>\n","protected":false},"author":2,"featured_media":11852,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-11858","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/posts\/11858","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/comments?post=11858"}],"version-history":[{"count":1,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/posts\/11858\/revisions"}],"predecessor-version":[{"id":11859,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/posts\/11858\/revisions\/11859"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/media\/11852"}],"wp:attachment":[{"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/media?parent=11858"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/categories?post=11858"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fbg.ub.edu\/en\/wp-json\/wp\/v2\/tags?post=11858"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}