Incannex has been given the green light to start its Phase 2 clinical trial to assess the safety and efficacy of IHL-675A, a combination drug that combines a specific proprietary formulation of CBD and another long standing prescription drug for rheumatoid arthritis.<\/p>\n
Biotech Incannex Healthcare (ASX:IHL)<\/strong><\/a>\u00a0 <\/strong>has received approval from Bellberry Human Research Ethics Committee (HREC) for the lead site Emeritus Research in Melbourne for its Phase 2 clinical trial.<\/p>\n The Phase 2 trial follows the successful Phase 1 clinical trial whereby both active\u00a0 pharmaceutical\u00a0 ingredients,\u00a0 cannabidiol\u00a0 (CBD)\u00a0 and\u00a0 hydroxychloroquine sulphate (HCQ) were absorbed from IHL\u2019s fixed dose combination product IHL-675A.The drug product was also observed to be well tolerated, with no adverse events of concern.<\/p>\n Before starting\u00a0 clinical\u00a0 trials, IHL\u00a0 observed\u00a0 positive\u00a0 results\u00a0 from\u00a0 an\u00a0 animal model\u00a0 of\u00a0 rheumatoid arthritis.<\/p>\n IHL-675A was observed to be more effective at reducing rheumatoid arthritis across multiple disease assessments including clinical score,\u00a0 paw\u00a0 volume,\u00a0 pannus\u00a0 score,\u00a0 total\u00a0 histology\u00a0 score\u00a0 and\u00a0 serum\u00a0 cytokine\u00a0 levels\u00a0 than\u00a0 the\u00a0 rodent equivalent of the standard dose of HCQ or equivalent doses of CBD.<\/p>\n The reduction in disease assessments achieved by IHL-675A was 1.06-3.52 times that observed for HCQ alone at the standard dose.<\/p>\n The promising observations led IHL to prioritise rapid clinical assessment, particularly given that HCQ, marketed as \u201cPlaquenil\u201d and generic equivalents, is a common long-standing treatment prescribed for rheumatoid arthritis with a considerable market profile.<\/p>\n The\u00a0 Phase\u00a0 2\u00a0 trial will\u00a0 assess\u00a0 the\u00a0 efficacy,\u00a0 safety\u00a0 and\u00a0 tolerability\u00a0 of\u00a0 IHL-675A\u00a0 compared\u00a0 to\u00a0 the respective\u00a0 component\u00a0 active\u00a0 pharmaceutical\u00a0 ingredients\u00a0 (APIs),\u00a0 CBD\u00a0 and\u00a0 HCQ,\u00a0 and\u00a0 placebo.<\/p>\n The treatments\u00a0 will\u00a0 be\u00a0 double\u00a0 blinded,\u00a0 meaning\u00a0 neither\u00a0 the\u00a0 investigators\u00a0 nor\u00a0 patients\u00a0 will\u00a0 know\u00a0 which treatment an individual is receiving.<\/p>\n The\u00a0 study will be managed by Avance Clinical, an Australian and US contract research organisation (CRO).<\/p>\n Recruitment\u00a0 of additional\u00a0 sites\u00a0 with\u00a0 experience\u00a0 in\u00a0 rheumatology\u00a0 clinical\u00a0 trials\u00a0 is\u00a0 ongoing,\u00a0 with\u00a0 the\u00a0 goal\u00a0 of\u00a0 8-10\u00a0 sites\u00a0 across Australia and New Zealand being included in the study.<\/p>\n The trial will have 128 participants who meet the eligibility criteria and is designed to include patients who have ongoing pain and reduced function while on stable treatment for rheumatoid arthritis.<\/p>\n Participants will be\u00a0 randomised\u00a0 to\u00a0 one\u00a0 of\u00a0 four\u00a0 arms including either\u00a0 IHL-675A,\u00a0 CBD\u00a0 alone,\u00a0 HCQ\u00a0 alone or placebo. \u00a0The\u00a0 primary endpoint for the study is pain and function relative to baseline determined via the score on the RAPID3\u00a0 assessment.<\/p>\n Participants\u00a0 will\u00a0 also\u00a0 record\u00a0 their\u00a0 pain\u00a0 and\u00a0 function\u00a0 outcomes\u00a0 daily,\u00a0 by completing questionnaires on pain, fatigue, joint stiffness, and quality of life.<\/p>\n The\u00a0 participants\u00a0 will\u00a0 attend\u00a0 monthly\u00a0 visits\u00a0 at\u00a0 the\u00a0 clinical\u00a0 trial\u00a0 site,\u00a0 where\u00a0 blood\u00a0 tests,\u00a0 and\u00a0 physical examinations will monitor additional safety and efficacy outcomes including inflammatory biomarkers.<\/p>\n The results of the trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the US FDA\u2019s new drug application dossier.<\/p>\n \u201cHREC approval for the Phase 2 clinical trial is a key step in the development of IHL-675A for treatment of pain and reduced function associated with rheumatoid arthritis,\u201d IHL chief scientific officer Dr Mark Bleackley said.<\/p>\n \u201cWe look forward to working with Emeritus and Avance to assess the effect of IHL- \u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/p>\n The post Incannex receives ethics approval to start Phase 2 clinical trial for combination drug for rheumatoid arthritis<\/a> appeared first on Stockhead<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" Incannex has been given the green light to start its Phase 2 clinical trial to assess the safety … Read MorePrimary endpoint of Phase 2 trial is pain and function<\/strong><\/h2>\n
Results critical for regulatory applications<\/strong><\/h2>\n
\n675A in this patient population.\u201d<\/p>\n
\nThe post Incannex receives ethics approval to start Phase 2 clinical trial for combination drug for rheumatoid arthritis appeared first on Stockhead.<\/p>\n","protected":false},"author":1,"featured_media":3443,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":0,"footnotes":""},"categories":[1,6],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3428"}],"collection":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/comments?post=3428"}],"version-history":[{"count":4,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3428\/revisions"}],"predecessor-version":[{"id":3445,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3428\/revisions\/3445"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/media\/3443"}],"wp:attachment":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/media?parent=3428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/categories?post=3428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/tags?post=3428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}